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Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial (THRIVE)

Primary Purpose

Surgery-Complications, Anesthesia Complication, Anesthesia Awareness

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anesthetic technique Propofol TIVA
Anesthetic technique inhaled agent
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgery-Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Each patient must meet all of the following criteria: Aged 18 years or older Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device) Exclusion Criteria Patients will not be enrolled if any of the following criteria are met: Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option) Pregnancy (based on patient report or positive test on the day of surgery) Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring). Locally approved, written protocol mandating a particular anesthetic technique History of intraoperative awareness during general anesthesia based on patient self-report Planned postoperative intubation Current incarceration

Sites / Locations

  • University of Michigan
  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol total intravenous anesthesia (TIVA)

inhaled volatile general anesthesia (INVA)

Arm Description

No administration of inhaled agent.

Must administer inhaled agent.

Outcomes

Primary Outcome Measures

Quality of Recovery-15 (QOR 15) score on POD1 after Major inpatient surgery
We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD1 after minor inpatient surgery
We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD1 after Outpatient surgery
We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Incidence of unintended intraoperative awareness with recall on POD1 or POD30
Determine whether the incidence of intraoperative awareness with TIVA is non-inferior to that with INVA. Otherwise stated, to determine whether TIVA confers no more than a small (0.2%) increased risk of intraoperative awareness than INVA.

Secondary Outcome Measures

Quality of Recovery-15 score on POD0 after major inpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD0 minor inpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD0 outpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[atient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Difference in baseline versus POD# (POD0, POD1, POD7) will be compared and assessed over the participants time in the study to measure the rate the participant returns to baseline QOR score. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD2 after major inpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD2 after minor inpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a)minor inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD2 after outpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD7 after major inpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD7 after minor inpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Quality of Recovery-15 score on POD7 after outpatient surgery
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[aitnet surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Incidence of delirium on POD0 after major inpatient surgery
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.
Incidence of delirium on POD0 after minor surgery
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing minor inpatient surgery.
Incidence of delirium on POD1 after major inpatient
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.
Incidence of delirium on POD1 after minor inpatient surgery
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.
Incidence of delirium on POD1 after outpatient surgery
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.
The Patient Health Questionnaire 4 (PHQ 4) on POD7 after major inpatient surgery
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having major inpatient surgery
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
The Patient Health Questionnaire 4 (PHQ 4) on POD7 after minor inpatient surgery
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having minor inpatient surgery
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
The Patient Health Questionnaire 4 (PHQ 4) on POD7 after outpatient surgery
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having outpatient surgery.
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
The Patient Health Questionnaire 8 (PHQ 8) on POD7 after minor inpatient surgery
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having minor inpatient surgery..
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
The Patient Health Questionnaire 8 (PHQ 8) on POD7 after major inpatient surgery
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having major inpatient surgery
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
The Patient Health Questionnaire 8 (PHQ 8) on POD7 after outpatient surgery
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having outpatient surgery
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after minor inpatient surgery
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having minor inpatient surgery
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after major inpatient surgery
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having major inpatient surgery
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after outpatient surgery
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having outpatient surgery
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Days alive and at-home at POD30 after major inpatient surgery
The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.
Days alive and at-home at POD30 after minor inpatient surgery
The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.
EQ-5D-5L Quality of life on POD30 after major inpatient surgery
EQ-5D-5L Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD30 after minor inpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD30 after outpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD90 after major inpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD90 after minor inpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD90 after outpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD180 after major inpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD180 after minor inpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD180 after outpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD365 after major inpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ - 5D-5L Quality of life on POD365 after minor inpatient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
EQ-5D-5L Quality of life on POD365 after out patient surgery
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Bauer Questionnaire - Patient satisfaction with anesthesia at POD2
Bauer questionnaire - Self-report satisfaction survey focused on satisfaction with anesthesia. Satisfaction is measured by reporting an experience as happening and if it did was it moderate or severe. As well as satisfaction for each aspect of anesthesia care: "very satisfied", "satisfied", "dissatisfied", or "very dissatisfied"
Respiratory failure on POD0
Respiratory failure on POD0
kidney injury on POD7
kidney injury on POD7
all-cause mortality at POD30
all-cause mortality at POD30
all-cause mortality at POD90
all-cause mortality at POD90
intraoperative hypotension
intraoperative hypotension
moderate to severe intraoperative patient movement
moderate to severe intraoperative patient movement
unplanned admission after outpatient surgery in an ambulatory setting
unplanned admission after outpatient surgery in an ambulatory setting
Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR
Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR
Incidence of malignant hyperthermia as reported in the EHR
Incidence of malignant hyperthermia as reported in the EHR

Full Information

First Posted
June 23, 2023
Last Updated
August 7, 2023
Sponsor
Washington University School of Medicine
Collaborators
Patient-Centered Outcomes Research Institute, University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05991453
Brief Title
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Acronym
THRIVE
Official Title
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
July 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Patient-Centered Outcomes Research Institute, University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will conduct a 12,500-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery-Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia, Surgery, Quality of Life, Pain, Postoperative, Anesthesia Morbidity, Depression, Sleep Disorders, Circadian Rhythm

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol total intravenous anesthesia (TIVA)
Arm Type
Active Comparator
Arm Description
No administration of inhaled agent.
Arm Title
inhaled volatile general anesthesia (INVA)
Arm Type
Active Comparator
Arm Description
Must administer inhaled agent.
Intervention Type
Other
Intervention Name(s)
Anesthetic technique Propofol TIVA
Other Intervention Name(s)
Propofol TIVA
Intervention Description
Propofol TIVA no inhaled agent
Intervention Type
Other
Intervention Name(s)
Anesthetic technique inhaled agent
Other Intervention Name(s)
Inhaled agent
Intervention Description
Must administer inhaled agent.
Primary Outcome Measure Information:
Title
Quality of Recovery-15 (QOR 15) score on POD1 after Major inpatient surgery
Description
We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
baseline to day 1
Title
Quality of Recovery-15 score on POD1 after minor inpatient surgery
Description
We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
baseline to day 1
Title
Quality of Recovery-15 score on POD1 after Outpatient surgery
Description
We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
baseline to day 1
Title
Incidence of unintended intraoperative awareness with recall on POD1 or POD30
Description
Determine whether the incidence of intraoperative awareness with TIVA is non-inferior to that with INVA. Otherwise stated, to determine whether TIVA confers no more than a small (0.2%) increased risk of intraoperative awareness than INVA.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Quality of Recovery-15 score on POD0 after major inpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Quality of Recovery-15 score on POD0 minor inpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Quality of Recovery-15 score on POD0 outpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[atient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type. Difference in baseline versus POD# (POD0, POD1, POD7) will be compared and assessed over the participants time in the study to measure the rate the participant returns to baseline QOR score. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Quality of Recovery-15 score on POD2 after major inpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Quality of Recovery-15 score on POD2 after minor inpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a)minor inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Quality of Recovery-15 score on POD2 after outpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Quality of Recovery-15 score on POD7 after major inpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Quality of Recovery-15 score on POD7 after minor inpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Quality of Recovery-15 score on POD7 after outpatient surgery
Description
We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[aitnet surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type. Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
Time Frame
7 days
Title
Incidence of delirium on POD0 after major inpatient surgery
Description
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.
Time Frame
1 day
Title
Incidence of delirium on POD0 after minor surgery
Description
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing minor inpatient surgery.
Time Frame
1 day
Title
Incidence of delirium on POD1 after major inpatient
Description
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.
Time Frame
1 day
Title
Incidence of delirium on POD1 after minor inpatient surgery
Description
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.
Time Frame
1 day
Title
Incidence of delirium on POD1 after outpatient surgery
Description
Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.
Time Frame
1 day
Title
The Patient Health Questionnaire 4 (PHQ 4) on POD7 after major inpatient surgery
Description
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
Time Frame
7 days
Title
The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having major inpatient surgery
Description
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
Time Frame
7 days
Title
The Patient Health Questionnaire 4 (PHQ 4) on POD7 after minor inpatient surgery
Description
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
Time Frame
7 days
Title
The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having minor inpatient surgery
Description
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
Time Frame
7 days
Title
The Patient Health Questionnaire 4 (PHQ 4) on POD7 after outpatient surgery
Description
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
Time Frame
7 days
Title
The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having outpatient surgery.
Description
The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
Time Frame
7 days
Title
The Patient Health Questionnaire 8 (PHQ 8) on POD7 after minor inpatient surgery
Description
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
Time Frame
7 days
Title
The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having minor inpatient surgery..
Description
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
Time Frame
7 days
Title
The Patient Health Questionnaire 8 (PHQ 8) on POD7 after major inpatient surgery
Description
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
Time Frame
7 days
Title
The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having major inpatient surgery
Description
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
Time Frame
7 days
Title
The Patient Health Questionnaire 8 (PHQ 8) on POD7 after outpatient surgery
Description
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
Time Frame
7 days
Title
The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having outpatient surgery
Description
The changes in anxiety and depression The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
Time Frame
7 days
Title
Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after minor inpatient surgery
Description
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Time Frame
7 days
Title
Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having minor inpatient surgery
Description
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Time Frame
7 days
Title
Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after major inpatient surgery
Description
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Time Frame
7 days
Title
Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having major inpatient surgery
Description
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Time Frame
7 days
Title
Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after outpatient surgery
Description
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Time Frame
7 days
Title
Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having outpatient surgery
Description
Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
Time Frame
7 days
Title
Days alive and at-home at POD30 after major inpatient surgery
Description
The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.
Time Frame
30 days
Title
Days alive and at-home at POD30 after minor inpatient surgery
Description
The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.
Time Frame
30 days
Title
EQ-5D-5L Quality of life on POD30 after major inpatient surgery
Description
EQ-5D-5L Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
30 days
Title
EQ-5D-5L Quality of life on POD30 after minor inpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
30 days
Title
EQ-5D-5L Quality of life on POD30 after outpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
30 days
Title
EQ-5D-5L Quality of life on POD90 after major inpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
90 days
Title
EQ-5D-5L Quality of life on POD90 after minor inpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
90 days
Title
EQ-5D-5L Quality of life on POD90 after outpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
90 days
Title
EQ-5D-5L Quality of life on POD180 after major inpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
180 days
Title
EQ-5D-5L Quality of life on POD180 after minor inpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
180 days
Title
EQ-5D-5L Quality of life on POD180 after outpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
180 days
Title
EQ-5D-5L Quality of life on POD365 after major inpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
365 days
Title
EQ - 5D-5L Quality of life on POD365 after minor inpatient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
365 days
Title
EQ-5D-5L Quality of life on POD365 after out patient surgery
Description
Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time. EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Time Frame
365 days
Title
Bauer Questionnaire - Patient satisfaction with anesthesia at POD2
Description
Bauer questionnaire - Self-report satisfaction survey focused on satisfaction with anesthesia. Satisfaction is measured by reporting an experience as happening and if it did was it moderate or severe. As well as satisfaction for each aspect of anesthesia care: "very satisfied", "satisfied", "dissatisfied", or "very dissatisfied"
Time Frame
2 days
Title
Respiratory failure on POD0
Description
Respiratory failure on POD0
Time Frame
1 day
Title
kidney injury on POD7
Description
kidney injury on POD7
Time Frame
7 days
Title
all-cause mortality at POD30
Description
all-cause mortality at POD30
Time Frame
30 days
Title
all-cause mortality at POD90
Description
all-cause mortality at POD90
Time Frame
90 days
Title
intraoperative hypotension
Description
intraoperative hypotension
Time Frame
90 days
Title
moderate to severe intraoperative patient movement
Description
moderate to severe intraoperative patient movement
Time Frame
90 days
Title
unplanned admission after outpatient surgery in an ambulatory setting
Description
unplanned admission after outpatient surgery in an ambulatory setting
Time Frame
90 days
Title
Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR
Description
Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR
Time Frame
90 days
Title
Incidence of malignant hyperthermia as reported in the EHR
Description
Incidence of malignant hyperthermia as reported in the EHR
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery.
Description
Daily step count at baseline - number of steps per day
Time Frame
1 - 7 days prior to surgery
Title
Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
Description
Daily step count at baseline - number of steps per day
Time Frame
1 - 7 days prior to surgery
Title
Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery.
Description
Daily step count at baseline - number of steps per day
Time Frame
1 - 7 days prior to surgery
Title
Daily step count as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
Time Frame
7 - 10 days after surgery
Title
Daily step count as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
Time Frame
7 - 10 days after surgery
Title
Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
Time Frame
7 - 10 days after surgery
Title
Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
Time Frame
30 - 34 days after surgery
Title
Daily step count as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
Time Frame
30 - 34 days after surgery
Title
Daily step count as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
Time Frame
30 - 34 days after surgery
Title
Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery.
Description
Daily standing hours: defined as standing hours per day
Time Frame
1 - 7 days prior to surgery
Title
Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
Description
Daily standing hours: defined as standing hours per day
Time Frame
1 - 7 days prior to surgery
Title
Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery.
Description
Daily standing hours: defined as standing hours per day
Time Frame
1 - 7 days prior to surgery
Title
Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
Time Frame
7 - 10 days after surgery
Title
Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
Time Frame
7 - 10 days after surgery
Title
Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
Time Frame
7 - 10 days after surgery
Title
Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
Time Frame
30 - 34 days after surgery
Title
Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
Time Frame
30 - 34 days after surgery
Title
Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device. Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
Time Frame
30 - 34 days after surgery
Title
Total sleep time as measured at baseline by wearable device for those scheduled for outpatient surgery.
Description
Total sleep time defined as minutes of total sleep time per day
Time Frame
1 - 7 days prior to surgery
Title
Total sleep time as measured at baseline by wearable device for those scheduled for major inpatient surgery.
Description
Total sleep time defined as minutes of total sleep time per day
Time Frame
1 - 7 days prior to surgery
Title
Total sleep time as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
Description
Total sleep time defined as minutes of total sleep time per day
Time Frame
1 - 7 days prior to surgery
Title
Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
Time Frame
7 - 10 days after surgery
Title
Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
Time Frame
7 - 10 days after surgery
Title
Total sleep time as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
Time Frame
7 - 10 days after surgery
Title
Total sleep time as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
Time Frame
30 - 34 days after surgery
Title
Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
Time Frame
30 - 34 days after surgery
Title
Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
Time Frame
30 - 34 days after surgery
Title
Sleep onset latency as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
Description
Sleep onset latency: defined as minutes of sleep onset latency per day
Time Frame
1 - 7 days prior to surgery
Title
Sleep onset latency as measured by wearable device at baseline for those scheduled for major inpatient surgery.
Description
Sleep onset latency: defined as minutes of sleep onset latency per day
Time Frame
1 - 7 days prior to surgery
Title
Sleep onset latency as measured by wearable device at baseline for those scheduled for outpatient surgery.
Description
Sleep onset latency: defined as minutes of sleep onset latency per day
Time Frame
1 - 7 days prior to surgery
Title
Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
Time Frame
7 - 10 days after surgery
Title
Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
Time Frame
7 - 10 days after surgery
Title
Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
Time Frame
7 - 10 days after surgery
Title
Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
Time Frame
30 - 34 days after surgery
Title
Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
Time Frame
30 - 34 days after surgery
Title
Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
Time Frame
30 - 34 days after surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
Description
Wake after sleep onset: defined as minutes of wake after sleep onset
Time Frame
1 - 7 days prior to surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
Description
Wake after sleep onset: defined as minutes of wake after sleep onset
Time Frame
1 - 7 days prior to surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Wake after sleep onset: defined as minutes of wake after sleep onset
Time Frame
1 - 7 days prior to surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
Time Frame
7 - 10 days after surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
Time Frame
7 - 10 days after surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
Time Frame
7 - 10 days after surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
Time Frame
30 - 34 days after surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
Time Frame
30 - 34 days after surgery
Title
Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
Time Frame
30 - 34 days after surgery
Title
Sleep efficiency as measured at baseline by wearable device for those scheduled for major inpatient surgery.
Description
Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)
Time Frame
1 - 7 days prior to surgery
Title
Sleep efficiency as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
Description
Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)
Time Frame
1 - 7 days prior to surgery
Title
Sleep efficiency as measured at baseline by wearable device for those scheduled for outpatient surgery.
Description
Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)
Time Frame
1 - 7 days prior to surgery
Title
Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
Time Frame
7 - 10 days after surgery
Title
Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
Time Frame
7 - 10 days after surgery
Title
Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
Time Frame
7 - 10 days after surgery
Title
Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
Time Frame
30 - 34 days after surgery
Title
Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
Time Frame
30 - 34 days after surgery
Title
Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
Time Frame
30 - 34 days after surgery
Title
Midpoint of sleep as measured at baseline by wearable device for those scheduled for outpatient surgery.
Description
Midpoint of sleep: defined as midpoint of sleep (time)
Time Frame
1 - 7 days prior to surgery
Title
Midpoint of sleep as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
Description
Midpoint of sleep: defined as midpoint of sleep (time)
Time Frame
1 - 7 days prior to surgery
Title
Midpoint of sleep as measured at baseline by wearable device for those scheduled for major inpatient surgery.
Description
Midpoint of sleep: defined as midpoint of sleep (time)
Time Frame
1 - 7 days prior to surgery
Title
Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
Time Frame
7 - 10 days after surgery
Title
Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
Time Frame
7 - 10 days after surgery
Title
Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
Time Frame
7 - 10 days after surgery
Title
Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
Time Frame
30 - 34 days after surgery
Title
Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
Time Frame
30 - 34 days after surgery
Title
Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.
Description
Measurement of outcomes will be median values measured on their wearable device Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
Time Frame
30 - 34 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Each patient must meet all of the following criteria: Aged 18 years or older Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device) Exclusion Criteria Patients will not be enrolled if any of the following criteria are met: Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option) Pregnancy (based on patient report or positive test on the day of surgery) Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring). Locally approved, written protocol mandating a particular anesthetic technique History of intraoperative awareness during general anesthesia based on patient self-report Planned postoperative intubation Current incarceration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Swisher
Phone
314-286-1024
Email
goodl@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sherry McKinnon
Phone
314-286-1024
Email
smckinnon@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Avidan, MBBcH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sachin Kheterpal, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Janda, MD
Email
ajanda@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Rachel Shoemake
Email
rahersho@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Sachin Kheterpal, MD
First Name & Middle Initial & Last Name & Degree
Allison Janda, MD
First Name & Middle Initial & Last Name & Degree
Sathish Kumar, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Swisher
Email
goodl@wustl.edu
First Name & Middle Initial & Last Name & Degree
Sherry McKinnon, MS
Email
smckinnon@wustl.edu
First Name & Middle Initial & Last Name & Degree
Michael S Avidan, MBBch
First Name & Middle Initial & Last Name & Degree
Stephen Gregory, MD

12. IPD Sharing Statement

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Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

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