Status:
RECRUITING
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
University of Michigan
Conditions:
Surgery-Complications
Anesthesia Complication
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Each patient must meet all of the following criteria:
- Aged 18 years or older
- 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:
- Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
- Pregnancy (based on patient report or positive test on the day of surgery)
- 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
- 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
- Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
- Locally approved, written protocol mandating a particular anesthetic technique
- History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
- Planned postoperative intubation
- Current incarceration
Exclusion
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
13000 Patients enrolled
Trial Details
Trial ID
NCT05991453
Start Date
September 13 2023
End Date
July 31 2028
Last Update
August 5 2025
Active Locations (20)
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1
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205
2
University of California San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305
4
Yale School of Medicine
New Haven, Connecticut, United States, 06510