The investigators will conduct a 13,000-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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
13,000
Propofol TIVA no inhaled agent
Must administer inhaled agent.
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGStanford University
Stanford, California, United States
NOT_YET_RECRUITINGYale School of Medicine
New Haven, Connecticut, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBrigham & Women's
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGHenry Ford Health
Detroit, Michigan, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGDartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
RECRUITING...and 10 more locations
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: Postoperative day 1
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: Postoperative day 1
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: Postoperative day 1
Incidence of definite intraoperative awareness with recall
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.
Time frame: Postoperative day 30
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 7
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 7
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Time frame: postoperative day 7
Days Alive and at Home at 30 days after major inpatient surgery
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.
Time frame: postoperative day 30
Days Alive and at Home at 30 days after minor inpatient surgery
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.
Time frame: postoperative day 30
Days Alive and at Home at 30 days after outpatient surgery
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.
Time frame: postoperative day 30
Incidence of delirium on postoperative day 0 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Time frame: postoperative day 0
Incidence of delirium on postoperative day 0 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Time frame: postoperative day 0
Incidence of delirium on postoperative day 0 after outpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Time frame: postoperative day 0
Incidence of delirium on postoperative day 1 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Time frame: postoperative day 1
Incidence of delirium on postoperative day 1 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.
Time frame: postoperative day 1
Delirium Severity Score on postoperative day 0 after major inpatient surgery
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.
Time frame: postoperative day 0
Delirium Severity Score on postoperative day 0 after minor inpatient surgery
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.
Time frame: postoperative day 0
Delirium Severity Score on postoperative day 0 after outpatient surgery
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.
Time frame: postoperative day 0
Delirium Severity Score on postoperative day 1 after major inpatient surgery
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.
Time frame: postoperative day 1
Delirium Severity Score on postoperative day 1 after minor inpatient surgery
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.
Time frame: postoperative day 1
Incidence of Subsyndromal delirium on postoperative day 0 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Time frame: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 0 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Time frame: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 0 after outpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Time frame: postoperative day 0
Incidence of Subsyndromal delirium on postoperative day 1 after major inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Time frame: postoperative day 1
Incidence of Subsyndromal delirium on postoperative day 1 after minor inpatient surgery
The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.
Time frame: postoperative day 1
Health-related quality-of-life on postoperative day 30 after major inpatient surgery
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
Time frame: postoperative day 30
Health-related quality-of-life on postoperative day 30 after minor inpatient surgery
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
Time frame: postoperative day 30
Health-related quality-of-life on postoperative day 30 after outpatient surgery
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
Time frame: postoperative day 30
Health-related quality-of-life on postoperative day 90 after major inpatient surgery
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
Time frame: postoperative day 90
Health-related quality-of-life on postoperative day 90 after minor inpatient surgery
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
Time frame: postoperative 90 days
Health-related quality-of-life on postoperative day 90 after outpatient surgery
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
Time frame: postoperative day 90
Health-related quality-of-life on postoperative day 180 after major inpatient surgery
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
Time frame: postoperative day 180
Health-related quality-of-life on postoperative day 180 after minor inpatient surgery
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
Time frame: postoperative day 180
Health-related quality-of-life on postoperative day 180 after outpatient surgery
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
Time frame: postoperative day 180
Health-related quality-of-life on postoperative day 365 after major inpatient surgery
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
Time frame: postoperative day 365
Health-related quality-of-life on postoperative day 365 after minor inpatient surgery
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
Time frame: postoperative day 365
Health-related quality-of-life on postoperative day 365 after outpatient surgery
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
Time frame: postoperative day 365
Functional status on postoperative day 30 after major inpatient surgery.
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.
Time frame: postoperative day 30
Functional status on postoperative day 30, after minor inpatient surgery.
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.
Time frame: postoperative day 30
Functional status on postoperative day 30, after outpatient surgery.
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.
Time frame: postoperative day 30
Functional status on postoperative day 90 after major inpatient surgery.
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.
Time frame: postoperative day 90
Functional status on postoperative day 90 after minor inpatient surgery.
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.
Time frame: postoperative day 90
Functional status on postoperative day 90 after outpatient surgery.
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.
Time frame: postoperative day 90
Patient satisfaction with anesthesia on postoperative day 2
The Bauer questionnaire is a patient self-reported survey assessing anesthesia-related discomfort and satisfaction with anesthesia care.
Time frame: postoperative day 2
Respiratory Failure on 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.
Time frame: postoperative day 0
Kidney Injury on postoperative day 7
Kidney Injury defined as a serum creatinine increase of 50% or 0.3 mg/dl from preoperative baseline
Time frame: postoperative day 7
All-Cause Mortality at POD30
All-Cause Mortality at POD30
Time frame: postoperative day 30
All-Cause Mortality at POD90
All-Cause Mortality at POD90
Time frame: postoperative day 90
Intraoperative Hypotension (1)
Intraoperative Hypotension defined as cumulative duration of mean arterial pressure \<55 mmHg for 20 minutes or greater.
Time frame: postoperative day 0
Intraoperative Hypotension (2)
Intraoperative hypotension defined as cumulative duration of mean arterial pressure \< 65 mmHg for 20 minutes or greater.
Time frame: postoperative day 0
Moderate or Severe Intraoperative Patient Movement
Moderate or Severe Intraoperative Patient Movement is based on clinician report.
Time frame: postoperative day 0
Unplanned Admission After Outpatient Surgery in an Ambulatory Setting
Hospital admission no later than 24 hours postoperatively after outpatient surgery in a free-standing ambulatory surgery center setting
Time frame: postoperative days 0 and 1
Incidence of propofol-related infusion syndrome
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.
Time frame: postoperative day 0
Incidence of malignant hyperthermia
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.
Time frame: postoperative day 0
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