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THRIVE Feasibility Trial (THRIVE)

Primary Purpose

Surgery--Complications, Anesthesia Complication, Anesthesia Awareness

Status
Active
Phase
Phase 3
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 focused on measuring Quality of recovery, Intraoperative awareness

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years or older
  • Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

Exclusion Criteria:

  • Inability to provide informed consent in English
  • 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 inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)
  • Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring).
  • Hospital approved, written protocol mandating a particular technique
  • History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent
  • Planned postoperative intubation

Sites / Locations

  • Stanford University
  • University of Michigan
  • Washington University School of Medicine
  • Hosptial of the University of Pennsylvania

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

Arm Description

No administration of inhaled agent.

Must administer inhaled agent.

Outcomes

Primary Outcome Measures

Proportion participating
Proportion of patients who are approached to participate by the study team and who consent to participate in the study.
Proportion receiving TIVA
Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).
Proportion receiving inhaled anesthesia
Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).

Secondary Outcome Measures

Completeness of data collection
Completeness of data collection (defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point and with each instrument)

Full Information

First Posted
March 11, 2022
Last Updated
May 23, 2023
Sponsor
Washington University School of Medicine
Collaborators
University of Michigan, University of Pennsylvania, Stanford University, Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05346588
Brief Title
THRIVE Feasibility Trial
Acronym
THRIVE
Official Title
Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
April 27, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

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

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
To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.
Detailed Description
Two-center single-blinded randomized feasibility study, with randomization 1:1 to either propofol TIVA or inhaled volatile general anesthesia for patients who are receiving elective non-cardiac surgery. Patients will be stratified by clinical site with 150 participants per site.

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 Emergence Delirium, Anesthesia, Surgery, Quality of Life, Pain, Postoperative, Nausea, Postoperative, Anesthesia Morbidity, Depression, Sleep Disorders, Circadian Rhythm
Keywords
Quality of recovery, Intraoperative awareness

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

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
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
Proportion participating
Description
Proportion of patients who are approached to participate by the study team and who consent to participate in the study.
Time Frame
8 months
Title
Proportion receiving TIVA
Description
Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).
Time Frame
8 months
Title
Proportion receiving inhaled anesthesia
Description
Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Completeness of data collection
Description
Completeness of data collection (defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point and with each instrument)
Time Frame
11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device) Exclusion Criteria: Inability to provide informed consent in English 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 inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring). Hospital approved, written protocol mandating a particular technique History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent Planned postoperative intubation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sachin Kheterpal, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael S Avidan, MBBcH
Organizational Affiliation
Washington Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hosptial of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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THRIVE Feasibility Trial

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