Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Purpose
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
Conditions
- Surgery-Complications
- Anesthesia Complication
- Anesthesia Awareness
- Anesthesia
- Surgery
- Quality of Life
- Pain, Postoperative
- Anesthesia Morbidity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Propofol total intravenous anesthesia (TIVA) |
No administration of inhaled agent. |
|
Active Comparator inhaled volatile general anesthesia (INVA) |
Must administer inhaled agent. |
|
Recruiting Locations
Little Rock 4119403, Arkansas 4099753 72205
San Francisco 5391959, California 5332921 94143
New Haven 4839366, Connecticut 4831725 06510
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02115
Ann Arbor 4984247, Michigan 5001836 48109
Detroit 4990729, Michigan 5001836 48202
St Louis 4407066, Missouri 4398678 63110
Lebanon 5088597, New Hampshire 5090174 03756
New York 5128581, New York 5128638 10012
New York 5128581, New York 5128638 10065
Durham 4464368, North Carolina 4482348 27708
Winston-Salem 4499612, North Carolina 4482348 27109
Portland 5746545, Oregon 5744337 97239
Houston 4699066, Texas 4736286 77030
Salt Lake City 5780993, Utah 5549030 84132
Charlottesville 4752031, Virginia 6254928 22908
Seattle 5809844, Washington 5815135 98195
More Details
- NCT ID
- NCT05991453
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine