Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Purpose
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
Conditions
- Surgery-Complications
- Anesthesia Complication
- Anesthesia Awareness
- Anesthesia
- Surgery
- Quality of Life
- Pain, Postoperative
- Anesthesia Morbidity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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, Arkansas 72205
San Francisco, California 94143
New Haven, Connecticut 06510
Boston, Massachusetts 02115
Saint Louis, Missouri 63110
Lebanon, New Hampshire 03756
Portland, Oregon 97239
Salt Lake City, Utah 84132
More Details
- NCT ID
- NCT05991453
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine