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Inhalational Anesthesia vs. Intravenous Anesthesia (GASvsIV)

Primary Purpose

Neurocognitive Disorders, Anesthesia, Post-operative Delirium

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurocognitive Disorders

Eligibility Criteria

75 Years - 105 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Men and women ≥ 75 years Sufficient vision and hearing to complete all tests Proficient in spoken and written English Scheduled for elective, inpatient, noncardiac surgery, expected to last at least 120 minutes requiring general anesthesia Informant available with frequent (at least 1 hour/day or 1 day/week) contact with the subject to verify CDR rating. Exclusion criteria: Urgent or emergent surgery Diagnosed dementia (or MoCA<19) History of stroke, Parkinson's disease, major psychiatric disease (Schizophrenia), or severe traumatic brain injury Ongoing alcohol or substance abuse (per DSM V criteria) Allergy to propofol or sevoflurane Personal or family history of malignant hyperthermia Planned postoperative intubation Brain surgery Surgery requiring TIVA or GAS (i.e. cases involving neuromonitoring) Surgical procedure requiring general, regional, or neuraxial anesthetic occurring within 3 months (before or after) surgical date Any patient or perioperative factor considered a contraindication to randomization to either experimental group by the surgeon or anesthesiologist.

Sites / Locations

  • Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inhalational Anesthesia

Intravenous Anesthesia

Arm Description

Inhalational maintenance of anesthesia group using sevoflurane

Intravenous maintenance of anesthesia group using propofol

Outcomes

Primary Outcome Measures

Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7.
Incidence of postoperative delirium with the 3D-Confusion Assessment Method (3D-CAM) in non-intubated patients and the CAM-ICU-7 in intubated patients. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3 while the patient is in the hospital.
Determine the effects of intravenous vs. inhalational anesthesia on the incidence of postoperative neurocognitive disorder in older adults undergoing non-cardiac surgery using neuropsychiatric composite score.
Postoperative neurocognitive disorder. Change from preoperative baseline cognitive dysfunction using neuropsychiatric composite score. Battery of neuropsychological tests: Animal Verbal Fluency Test, Trail Making Test A & B, Digit Symbol Test, Logical Memory Immediate & Delayed Recall, and CERAD Word List Immediate and Delayed recall. MASQ will be used for subjective cognitive decline. Functional status will be measured by FAQ.

Secondary Outcome Measures

Determine the effects of intravenous vs. inhalational anesthesia on incidence of delirium duration (days) and severity, measured by 3D-CAM-S, and CAM-ICU-7 in older adults undergoing non-cardiac surgery.
delirium severity and duration. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3.
Effects of intravenous vs. inhalational anesthesia on levels of blood phosphorylated tau 181 (p-tau181) in older surgical patients.. Change from preoperative baseline blood p-tau181 to postoperative day 1, 3 months and 12 months.
change in levels of preoperative levels of blood p-tau181 from preoperative baseline to 12 months postoperative
Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline using ADL, FAQ, and FRAIL in older adults undergoing non-cardiac surgery.
Incidence of postoperative functional decline. Change from preoperative baseline postoperative functional decline to postoperative 12 months.
Determine the effects of intravenous vs. inhalational anesthesia on patient-reported outcomes (PROMIS-29+2 Profile v2.1) in older adults undergoing non-cardiac surgery.
patient-reported outcome scores, PROMIS-29+2 Profile v2.1 (PROPr) assesses patient-reported measures of anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, participation in social activities, pain, and cognition. Measured at preoperative baseline, 3 months postoperatively, and 12 months postoperatively

Full Information

First Posted
April 18, 2023
Last Updated
September 6, 2023
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT06036095
Brief Title
Inhalational Anesthesia vs. Intravenous Anesthesia
Acronym
GASvsIV
Official Title
Optimizing Anesthesia to Prevent Postoperative Cognitive and Functional Decline in Older Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

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

5. Study Description

Brief Summary
Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious postoperative outcomes in the geriatric surgical population. The goal of this clinical trial is to determine whether intravenous anesthesia (IV) leads to a decreased incidence of postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and functional decline, and improved patient-reported outcomes (PROs) in older adults undergoing non-cardiac surgery when compared to the standard inhalational anesthesia (GAS). This single-center, 1:1 randomized, double-blind (patient & outcome assessor) clinical trial will compare inhalational vs. intravenous anesthesia on POD, POCD, functional status, patient-reported outcomes (PROs), and blood-based biomarkers in older patients undergoing elective, inpatient, non-cardiac surgery. Upon enrollment, 260 women and men ≥ 75 years undergoing elective noncardiac surgery under general anesthesia will be randomized to 2 groups: IV or GAS.
Detailed Description
Aim 1: Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium and postoperative cognitive dysfunction in older adults undergoing non-cardiac surgery. Hypothesis: Intravenous anesthesia is associated with a lower incidence of POD and POCD compared to inhalational anesthesia. Primary outcomes: Incidence of postoperative delirium and postoperative cognitive dysfunction Secondary outcomes: delirium severity, delirium duration Aim 2: Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline and patient-reported outcomes in older adults undergoing non-cardiac surgery. Hypothesis: Intravenous anesthesia is associated with a lower incidence of postoperative functional decline and improved patient-reported outcomes (PROs) compared to inhalational anesthesia. Primary outcomes: Incidence of postoperative functional decline; patient-reported outcome scores Aim 3: Determine the effects of intravenous vs. inhalational anesthesia on blood phosphorylated tau 181 (p-tau181) and other blood biomarkers in older adults undergoing non-cardiac surgery. Hypothesis 1: Elevated preop blood p-tau181 is associated with increased POD and POCD; Hypothesis 2: Postoperative increase in blood p-tau181 is greater with GAS relative to IV; Hypothesis 3: Postop increases in blood biomarkers of neuroinflammation and AD pathology are greater with GAS relative to IV. Primary outcomes: preoperative levels of blood p-tau181 and change in levels from preoperative baseline to postoperative. Secondary outcomes: Other candidate biomarkers include those previously implicated in POD or POCD: p-tau217, Aβ,54 NF-L,55 High mobility group box protein 1 (HMGB1),60 S100β,76 interleukin (IL)-6,58 IL-1β,22 IL-10,46 tumor necrosis factor (TNF)-α,22 CCL2,62 and glial fibrillary acidic protein (GFAP).77

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Disorders, Anesthesia, Post-operative Delirium, Post-operative Cognitive Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This single-center, 1:1 randomized, double-blind (patient & outcome assessor) clinical trial will compare inhalational (sevoflurane) vs. intravenous (propofol) anesthesia on POD, POCD, functional status, PROs, and biomarkers in patients ≥ 75 years undergoing elective, inpatient, non-cardiac surgery at Oregon Health & Science University.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhalational Anesthesia
Arm Type
Active Comparator
Arm Description
Inhalational maintenance of anesthesia group using sevoflurane
Arm Title
Intravenous Anesthesia
Arm Type
Active Comparator
Arm Description
Intravenous maintenance of anesthesia group using propofol
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Inhalational Anesthesia
Intervention Description
Inhalational maintenance of anesthesia group using sevoflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Intravenous Anesthesia
Intervention Description
Intravenous maintenance of anesthesia group using propofol
Primary Outcome Measure Information:
Title
Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7.
Description
Incidence of postoperative delirium with the 3D-Confusion Assessment Method (3D-CAM) in non-intubated patients and the CAM-ICU-7 in intubated patients. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3 while the patient is in the hospital.
Time Frame
through postoperative day 3
Title
Determine the effects of intravenous vs. inhalational anesthesia on the incidence of postoperative neurocognitive disorder in older adults undergoing non-cardiac surgery using neuropsychiatric composite score.
Description
Postoperative neurocognitive disorder. Change from preoperative baseline cognitive dysfunction using neuropsychiatric composite score. Battery of neuropsychological tests: Animal Verbal Fluency Test, Trail Making Test A & B, Digit Symbol Test, Logical Memory Immediate & Delayed Recall, and CERAD Word List Immediate and Delayed recall. MASQ will be used for subjective cognitive decline. Functional status will be measured by FAQ.
Time Frame
Change from preoperative baseline to one year.
Secondary Outcome Measure Information:
Title
Determine the effects of intravenous vs. inhalational anesthesia on incidence of delirium duration (days) and severity, measured by 3D-CAM-S, and CAM-ICU-7 in older adults undergoing non-cardiac surgery.
Description
delirium severity and duration. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3.
Time Frame
through postoperative day 3
Title
Effects of intravenous vs. inhalational anesthesia on levels of blood phosphorylated tau 181 (p-tau181) in older surgical patients.. Change from preoperative baseline blood p-tau181 to postoperative day 1, 3 months and 12 months.
Description
change in levels of preoperative levels of blood p-tau181 from preoperative baseline to 12 months postoperative
Time Frame
Change from baseline through one year.
Title
Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline using ADL, FAQ, and FRAIL in older adults undergoing non-cardiac surgery.
Description
Incidence of postoperative functional decline. Change from preoperative baseline postoperative functional decline to postoperative 12 months.
Time Frame
Change from baseline through one year
Title
Determine the effects of intravenous vs. inhalational anesthesia on patient-reported outcomes (PROMIS-29+2 Profile v2.1) in older adults undergoing non-cardiac surgery.
Description
patient-reported outcome scores, PROMIS-29+2 Profile v2.1 (PROPr) assesses patient-reported measures of anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, participation in social activities, pain, and cognition. Measured at preoperative baseline, 3 months postoperatively, and 12 months postoperatively
Time Frame
Change from baseline through one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Men and women ≥ 75 years Sufficient vision and hearing to complete all tests Proficient in spoken and written English Scheduled for elective, inpatient, noncardiac surgery, expected to last at least 120 minutes requiring general anesthesia Informant available with frequent (at least 1 hour/day or 1 day/week) contact with the subject to verify CDR rating. Exclusion criteria: Urgent or emergent surgery Diagnosed dementia (or MoCA<19) History of stroke, Parkinson's disease, major psychiatric disease (Schizophrenia), or severe traumatic brain injury Ongoing alcohol or substance abuse (per DSM V criteria) Allergy to propofol or sevoflurane Personal or family history of malignant hyperthermia Planned postoperative intubation Brain surgery Surgery requiring TIVA or GAS (i.e. cases involving neuromonitoring) Surgical procedure requiring general, regional, or neuraxial anesthetic occurring within 3 months (before or after) surgical date Any patient or perioperative factor considered a contraindication to randomization to either experimental group by the surgeon or anesthesiologist.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly N. Chun, BS
Phone
503-494-7437
Email
chunk@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah L. Feller, BS
Phone
503-494-6233
Email
fellersa@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie J. Schenning, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Feller, BS
Email
fellersa@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kimberly Chun, BS
Email
chunk@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Katie Schenning, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In order to promote advancement of this field of study, we will make data generated from this project available. Participants will sign a data repository consent form so de-identified data is able to be maintained indefinitely on secure servers at Oregon Health & Science University. This will enable us to combine these data with other datasets for future analyses, and to share with collaborators and other interested scientists. Other researchers would sign a data use agreement and then receive the de-identified data requested.

Learn more about this trial

Inhalational Anesthesia vs. Intravenous Anesthesia

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