Clinical trial NCT05991453: Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Official title: Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery-Complications
Anesthesia Complication
Anesthesia Awareness
Anesthesia
Surgery
Quality of Life
Pain, Postoperative
Anesthesia Morbidity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Michigan
First posted: 2023-08-14
Enrollment: 12500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria

Each patient must meet all of the following criteria:

1. Aged 18 years or older
2. 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:

1. Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
2. Pregnancy (based on patient report or positive test on the day of surgery)
3. 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
4. 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
5. Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
6. Locally approved, written protocol mandating a particular anesthetic technique
7. History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
8. Planned postoperative intubation
9. Current incarceration

Primary outcomes:
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery
timeFrame: Postoperative day 1
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery
timeFrame: Postoperative day 1
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery
timeFrame: Postoperative day 1
measure: Incidence of definite intraoperative awareness with recall
timeFrame: Postoperative day 30
Secondary outcomes:
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery
timeFrame: postoperative day 0
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery
timeFrame: postoperative day 0
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery
timeFrame: postoperative day 0
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery
timeFrame: postoperative day 2
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery
timeFrame: postoperative day 2
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery
timeFrame: postoperative day 2
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery
timeFrame: postoperative day 7
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery
timeFrame: postoperative day 7
measure: Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery
timeFrame: postoperative day 7
measure: Days Alive and at Home at 30 days after major inpatient surgery
timeFrame: postoperative day 30
measure: Days Alive and at Home at 30 days after minor inpatient surgery
timeFrame: postoperative day 30
measure: Days Alive and at Home at 30 days after outpatient surgery
timeFrame: postoperative day 30
measure: Incidence of delirium on postoperative day 0 after major inpatient surgery
timeFrame: postoperative day 0
measure: Incidence of delirium on postoperative day 0 after minor inpatient surgery
timeFrame: postoperative day 0
measure: Incidence of delirium on postoperative day 0 after outpatient surgery
timeFrame: postoperative day 0
measure: Incidence of delirium on postoperative day 1 after major inpatient surgery
timeFrame: postoperative day 1
measure: Incidence of delirium on postoperative day 1 after minor inpatient surgery
timeFrame: postoperative day 1
measure: Delirium Severity Score on postoperative day 0 after major inpatient surgery
timeFrame: postoperative day 0
measure: Delirium Severity Score on postoperative day 0 after minor inpatient surgery
timeFrame: postoperative day 0
measure: Delirium Severity Score on postoperative day 0 after outpatient surgery
timeFrame: postoperative day 0
measure: Delirium Severity Score on postoperative day 1 after major inpatient surgery
timeFrame: postoperative day 1
measure: Delirium Severity Score on postoperative day 1 after minor inpatient surgery
timeFrame: postoperative day 1
measure: Incidence of Subsyndromal delirium on postoperative day 0 after major inpatient surgery
timeFrame: postoperative day 0
measure: Incidence of Subsyndromal delirium on postoperative day 0 after minor inpatient surgery
timeFrame: postoperative day 0
measure: Incidence of Subsyndromal delirium on postoperative day 0 after outpatient surgery
timeFrame: postoperative day 0
measure: Incidence of Subsyndromal delirium on postoperative day 1 after major inpatient surgery
timeFrame: postoperative day 1
measure: Incidence of Subsyndromal delirium on postoperative day 1 after minor inpatient surgery
timeFrame: postoperative day 1
measure: Health-related quality-of-life on postoperative day 30 after major inpatient surgery
timeFrame: postoperative day 30
measure: Health-related quality-of-life on postoperative day 30 after minor inpatient surgery
timeFrame: postoperative day 30
measure: Health-related quality-of-life on postoperative day 30 after outpatient surgery
timeFrame: postoperative day 30
measure: Health-related quality-of-life on postoperative day 90 after major inpatient surgery
timeFrame: postoperative day 90
measure: Health-related quality-of-life on postoperative day 90 after minor inpatient surgery
timeFrame: postoperative 90 days
measure: Health-related quality-of-life on postoperative day 90 after outpatient surgery
timeFrame: postoperative day 90
measure: Health-related quality-of-life on postoperative day 180 after major inpatient surgery
timeFrame: postoperative day 180
measure: Health-related quality-of-life on postoperative day 180 after minor inpatient surgery
timeFrame: postoperative day 180
measure: Health-related quality-of-life on postoperative day 180 after outpatient surgery
timeFrame: postoperative day 180
measure: Health-related quality-of-life on postoperative day 365 after major inpatient surgery
timeFrame: postoperative day 365
measure: Health-related quality-of-life on postoperative day 365 after minor inpatient surgery
timeFrame: postoperative day 365
measure: Health-related quality-of-life on postoperative day 365 after outpatient surgery
timeFrame: postoperative day 365
measure: Functional status on postoperative day 30 after major inpatient surgery.
timeFrame: postoperative day 30
measure: Functional status on postoperative day 30, after minor inpatient surgery.
timeFrame: postoperative day 30
measure: Functional status on postoperative day 30, after outpatient surgery.
timeFrame: postoperative day 30
measure: Functional status on postoperative day 90 after major inpatient surgery.
timeFrame: postoperative day 90
measure: Functional status on postoperative day 90 after minor inpatient surgery.
timeFrame: postoperative day 90
measure: Functional status on postoperative day 90 after outpatient surgery.
timeFrame: postoperative day 90
measure: Patient satisfaction with anesthesia on postoperative day 2
timeFrame: postoperative day 2
measure: Respiratory Failure on postoperative day 0
timeFrame: postoperative day 0
measure: Kidney Injury on postoperative day 7
timeFrame: postoperative day 7
measure: All-Cause Mortality at POD30
timeFrame: postoperative day 30
measure: All-Cause Mortality at POD90
timeFrame: postoperative day 90
measure: Intraoperative Hypotension (1)
timeFrame: postoperative day 0
measure: Intraoperative Hypotension (2)
timeFrame: postoperative day 0
measure: Moderate or Severe Intraoperative Patient Movement
timeFrame: postoperative day 0
measure: Unplanned Admission After Outpatient Surgery in an Ambulatory Setting
timeFrame: postoperative days 0 and 1
measure: Incidence of propofol-related infusion syndrome
timeFrame: postoperative day 0
measure: Incidence of malignant hyperthermia
timeFrame: postoperative day 0
Other outcomes:
measure: Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Daily step count as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Daily step count as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Daily step count as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Daily step count as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Total sleep time as measured at baseline by wearable device for those scheduled for outpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Total sleep time as measured at baseline by wearable device for those scheduled for major inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Total sleep time as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Total sleep time as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Total sleep time as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Sleep onset latency as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Sleep onset latency as measured by wearable device at baseline for those scheduled for major inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Sleep onset latency as measured by wearable device at baseline for those scheduled for outpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Sleep efficiency as measured at baseline by wearable device for those scheduled for major inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Sleep efficiency as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Sleep efficiency as measured at baseline by wearable device for those scheduled for outpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Midpoint of sleep as measured at baseline by wearable device for those scheduled for outpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Midpoint of sleep as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Midpoint of sleep as measured at baseline by wearable device for those scheduled for major inpatient surgery.
timeFrame: 1 - 7 days prior to surgery
measure: Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 7 - 10 days after surgery
measure: Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.
timeFrame: 30 - 34 days after surgery
measure: Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.
timeFrame: 30 - 34 days after surgery
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences (UAMS)
state: Arkansas
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas - MD Anderson
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Medical
state: Utah
city: Charlottesville
country: United States
facility: UVA Health
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Michigan
name: Sachin Kheterpal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Michael S Avidan, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Allison Janda, MD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Mark Neuman, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Bethany Pennington, PharmD
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Douglas Colquhoun, MBChB
role: STUDY_DIRECTOR
References: