Anesthesia, Anesthesia Awareness, Anesthesia Complication, Anesthesia Morbidity, Pain, Postoperative, Quality of Life, Surgery, Surgery-Complications
Conditions
Brief summary
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
Interventions
Propofol TIVA no inhaled agent
Must administer inhaled agent.
Sponsors
Washington University School of Medicine
Patient-Centered Outcomes Research Institute
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 0 after outpatient surgery | postoperative day 0 | The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. |
| 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 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 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 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. |
| 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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. |
| 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. |
| 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 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 |
| 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 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 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 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 |
| 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 |
| 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 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 |
| 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 |
| 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 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. |
| 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 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 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| All-Cause Mortality at POD30 | postoperative day 30 | All-Cause Mortality at POD30 |
| All-Cause Mortality at POD90 | postoperative day 90 | All-Cause Mortality at POD90 |
| Intraoperative Hypotension (1) | postoperative day 0 | Intraoperative Hypotension defined as cumulative duration of mean arterial pressure \<55 mmHg for 20 minutes or greater. |
| Intraoperative Hypotension (2) | postoperative day 0 | Intraoperative hypotension defined as cumulative duration of mean arterial pressure \< 65 mmHg for 20 minutes or greater. |
| Moderate or Severe Intraoperative Patient Movement | postoperative day 0 | Moderate or Severe Intraoperative Patient Movement is based on clinician report. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTLaura Swisher
CONTACTSherry McKinnon
PRINCIPAL_INVESTIGATORSachin Kheterpal, MD
University of Michigan
PRINCIPAL_INVESTIGATORMichael S Avidan, MBBCh
Washington University School of Medicine
STUDY_DIRECTORAllison Janda, MD
University of Michigan
STUDY_DIRECTORMark Neuman, MD
University of Pennsylvania
STUDY_DIRECTORBethany Pennington, PharmD
Washington University School of Medicine
STUDY_DIRECTORDouglas Colquhoun, MBChB
University of Michigan
Outcome results
None listed