Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
- Conditions
- Pain, PostoperativeSurgeryAnesthesia MorbidityAnesthesia AwarenessSurgery-ComplicationsAnesthesia ComplicationAnesthesiaQuality of Life
- Interventions
- Other: Anesthetic technique Propofol TIVAOther: Anesthetic technique inhaled agent
- Registration Number
- NCT05991453
- Lead Sponsor
- Washington University School of Medicine
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol total intravenous anesthesia (TIVA) Anesthetic technique Propofol TIVA No administration of inhaled agent. inhaled volatile general anesthesia (INVA) Anesthetic technique inhaled agent Must administer inhaled agent.
- Primary Outcome Measures
Name Time Method Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery Postoperative day 1 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery Postoperative day 1 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery Postoperative day 1 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Incidence of definite intraoperative awareness with recall Postoperative day 30 The modified Brice questionnaire is used to screen for intraoperative awareness. A positive screen (a patient who reports remembering anything between going to sleep for their surgical procedure and waking up after) on the modified Brice questionnaire is followed by a structured interview. A panel of expert adjudicators determines whether or not this was definite intraoperative awareness.
- Secondary Outcome Measures
Name Time Method Days Alive and at Home at 30 days after minor inpatient surgery postoperative day 30 Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.
Incidence of delirium on postoperative day 0 after major inpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Incidence of delirium on postoperative day 0 after minor inpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Incidence of delirium on postoperative day 1 after minor inpatient surgery postoperative day 1 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Health-related quality-of-life on postoperative day 30 after major inpatient surgery postoperative day 30 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery postoperative day 0 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery postoperative day 2 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Incidence of delirium on postoperative day 0 after outpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Incidence of Subsyndromal delirium on postoperative day 0 after minor inpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery postoperative day 2 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Delirium Severity Score on postoperative day 1 after major inpatient surgery postoperative day 1 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Incidence of Subsyndromal delirium on postoperative day 1 after major inpatient surgery postoperative day 1 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Health-related quality-of-life on postoperative day 180 after major inpatient surgery postoperative day 180 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Kidney Injury on postoperative day 7 postoperative day 7 Kidney Injury defined as a serum creatinine increase of 50% or 0.3 mg/dl from preoperative baseline
Intraoperative Hypotension (2) postoperative day 0 Intraoperative hypotension defined as cumulative duration of mean arterial pressure \< 65 mmHg for 20 minutes or greater.
Incidence of malignant hyperthermia postoperative day 0 Malignant hyperthermia, defined as unexplained muscle rigidity, tachycardia, hypercapnia, and rapidly increasing temperature leading to metabolic acidosis, rhabdomyolysis, disseminated intravascular coagulation, and ventricular arrhythmias, occurring after the start of an inhaled volatile agent intraoperatively and within 6 hours postoperatively.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery postoperative day 0 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery postoperative day 0 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery postoperative day 2 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery postoperative day 7 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery postoperative day 7 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery postoperative day 7 The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Days Alive and at Home at 30 days after major inpatient surgery postoperative day 30 Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.
Days Alive and at Home at 30 days after outpatient surgery postoperative day 30 Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.
Delirium Severity Score on postoperative day 1 after minor inpatient surgery postoperative day 1 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Incidence of Subsyndromal delirium on postoperative day 0 after major inpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Incidence of delirium on postoperative day 1 after major inpatient surgery postoperative day 1 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Delirium Severity Score on postoperative day 0 after major inpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Delirium Severity Score on postoperative day 0 after minor inpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Delirium Severity Score on postoperative day 0 after outpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.
Incidence of Subsyndromal delirium on postoperative day 0 after outpatient surgery postoperative day 0 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Health-related quality-of-life on postoperative day 180 after outpatient surgery postoperative day 180 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Incidence of Subsyndromal delirium on postoperative day 1 after minor inpatient surgery postoperative day 1 The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Health-related quality-of-life on postoperative day 365 after outpatient surgery postoperative day 365 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Functional status on postoperative day 90 after minor inpatient surgery. postoperative day 90 The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Respiratory Failure on postoperative day 0 postoperative day 0 Respiratory failure defined as unplanned postoperative intubation or reintubation or continued mechanical ventilation \> 6 hours postoperatively. Reintubation due to reoperation is excluded.
Health-related quality-of-life on postoperative day 90 after major inpatient surgery postoperative day 90 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Health-related quality-of-life on postoperative day 30 after minor inpatient surgery postoperative day 30 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Health-related quality-of-life on postoperative day 180 after minor inpatient surgery postoperative day 180 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Health-related quality-of-life on postoperative day 365 after major inpatient surgery postoperative day 365 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Health-related quality-of-life on postoperative day 365 after minor inpatient surgery postoperative day 365 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Functional status on postoperative day 30, after minor inpatient surgery. postoperative day 30 The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Functional status on postoperative day 90 after major inpatient surgery. postoperative day 90 The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Health-related quality-of-life on postoperative day 30 after outpatient surgery postoperative day 30 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Health-related quality-of-life on postoperative day 90 after minor inpatient surgery postoperative 90 days EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Health-related quality-of-life on postoperative day 90 after outpatient surgery postoperative day 90 EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
Functional status on postoperative day 30 after major inpatient surgery. postoperative day 30 The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
All-Cause Mortality at POD30 postoperative day 30 All-Cause Mortality at POD30
Intraoperative Hypotension (1) postoperative day 0 Intraoperative Hypotension defined as cumulative duration of mean arterial pressure \<55 mmHg for 20 minutes or greater.
Functional status on postoperative day 30, after outpatient surgery. postoperative day 30 The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Functional status on postoperative day 90 after outpatient surgery. postoperative day 90 The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.
Patient satisfaction with anesthesia on postoperative day 2 postoperative day 2 The Bauer questionnaire is a patient self-reported survey assessing anesthesia-related discomfort and satisfaction with anesthesia care.
Unplanned Admission After Outpatient Surgery in an Ambulatory Setting postoperative days 0 and 1 Hospital admission no later than 24 hours postoperatively after outpatient surgery in a free-standing ambulatory surgery center setting
All-Cause Mortality at POD90 postoperative day 90 All-Cause Mortality at POD90
Moderate or Severe Intraoperative Patient Movement postoperative day 0 Moderate or Severe Intraoperative Patient Movement is based on clinician report.
Incidence of propofol-related infusion syndrome postoperative day 0 Propofol related infusion syndrome, defined as acute refractory bradycardia in the presence of metabolic acidosis, and at least one of the following: rhabdomyolysis, acute kidney injury or hypertriglyceridemia, occurring after the start of propofol intraoperatively and within 6 hours postoperatively.
Trial Locations
- Locations (20)
University of Arkansas for Medical Sciences (UAMS)
🇺🇸Little Rock, Arkansas, United States
UVA Health
🇺🇸Charlottesville, Virginia, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Women's
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas - MD Anderson
🇺🇸Houston, Texas, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Utah - Medical
🇺🇸Salt Lake City, Utah, United States
Stanford University
🇺🇸Stanford, California, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
NYU Langone
🇺🇸New York, New York, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Wake Forest
🇺🇸Winston-Salem, North Carolina, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Washington
🇺🇸Seattle, Washington, United States