Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Recruiting now · Not applicable

Conditions studied: Surgery-Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia, Surgery, Quality of Life, Pain, Postoperative, Anesthesia Morbidity

In brief

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

Key facts

Study ID

NCT05991453

Run by

Washington University School of Medicine

People needed

13000

Starts

2023-09-13

Expected to finish

2028-07-31

Last updated by the study team

2025-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Washington — Seattle, Washington, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• UVA Health — Charlottesville, Virginia, United States (enrolling)
• University of Arkansas for Medical Sciences (UAMS) — Little Rock, Arkansas, United States (enrolling)
• Yale School of Medicine — New Haven, Connecticut, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham & Women's — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (enrolling)
• NYU Langone — New York, New York, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Wake Forest — Winston-Salem, North Carolina, United States (enrolling)
• Oregon Health and Sciences University — Portland, Oregon, United States (enrolling)
• University of Texas - MD Anderson — Houston, Texas, United States (enrolling)
• University of Utah - Medical — Salt Lake City, Utah, United States (enrolling)
• Stanford University — Stanford, California, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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