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NCT05991453NARecruiting

Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Washington University School of Medicine

Start Date

9/13/2023

Completion Date

7/31/2028

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Anesthetic technique Propofol TIVA

OTHER

Anesthetic technique inhaled agent

Interested in This Trial?

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Conditions

Surgery-ComplicationsAnesthesia ComplicationAnesthesia AwarenessAnesthesiaSurgeryQuality of LifePain, PostoperativeAnesthesia Morbidity

Locations

University of Arkansas for Medical Sciences (UAMS)

Little Rock, Arkansas 72205

United States

University of California San Francisco

San Francisco, California 94143

United States

Stanford University

Stanford, California 94305

United States

Yale School of Medicine

New Haven, Connecticut 06510

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Brigham & Women's

Boston, Massachusetts 02115

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Health

Detroit, Michigan 48202

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

NYU Langone

New York, New York 10012

United States

Weill Cornell Medicine

New York, New York 10065

United States

Duke University

Durham, North Carolina 27708

United States

Wake Forest

Winston-Salem, North Carolina 27109

United States

Oregon Health and Sciences University

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Texas - MD Anderson

Houston, Texas 77030

United States

University of Utah - Medical

Salt Lake City, Utah 84132

United States

UVA Health

Charlottesville, Virginia 22908

United States

University of Washington

Seattle, Washington 98195

United States