Recruiting

Propofol vs. Volatile Anesthesia

Sponsor:

Washington University School of Medicine

Code:

NCT05991453

Conditions

Surgery-Complications

Anesthesia Complication

Anesthesia Awareness

Anesthesia

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anesthetic technique Propofol TIVA

Anesthetic technique inhaled agent

Study Details

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 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

Study ID

NCT05991453

Start date

Sep 13, 2023

Status verified date

Sep, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

13000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Propofol total intravenous anesthesia (TIVA)

No administration of inhaled agent.

active comparator: inhaled volatile general anesthesia (INVA)

Must administer inhaled agent.

Interventions

Anesthetic technique Propofol TIVA

Propofol TIVA no inhaled agent

Anesthetic technique inhaled agent

Must administer inhaled agent.

Primary outcome measure

  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery [ Time Frame: Postoperative day 1 ]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery [ Time Frame: Postoperative day 1 ]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery [ Time Frame: Postoperative day 1 ]
  • Incidence of definite intraoperative awareness with recall [ Time Frame: Postoperative day 30 ]

Central Contacts and Locations

Central contacts

Locations

University of Arkansas for Medical Sciences (UAMS)

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Geoffrey Muller, MD

gdmuller@uams.edu

Gwendolyn Cobbs

gfcobbs@uams.edu

Principal Investigator:

Geoffrey Muller, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Lee-lynn Chen, MD

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Jaime B Hyman, MD

jaime.hyman@yale.edu

Principal Investigator:

Jaime B Hyman, MD

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Joseph Walpole, MD, PhD

jwalpol1@jhmi.edu

Principal Investigator:

Joseph Walpole, MD, PhD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Amit Bardia, MD

abardia@mgb.org

Ariel Mueller, MA

almueller@mgh.harvard.edu

Principal Investigator:

Amit Bardia, MD

Brigham & Women's

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Luigino Nascimben, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Allison Janda, MD

ajanda@med.umich.edu

Rachel Shoemake

rahersho@med.umich.edu

Principal Investigator:

Sachin Kheterpal, MD

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Anoop Chhina, MD

achhina1@hfhs.org

Katherine Nowak, PhD

KNowak2@hfhs.org

Principal Investigator:

Anoop Chhina, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Laura Swisher

goodl@wustl.edu

Sherry McKinnon, MS

smckinnon@wustl.edu

Principal Investigator:

Michael S Avidan, MBBch

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Stacie Deiner, MD

NYU Langone

Recruiting

New York, New York, United States, 10012

Contacts

Principal Investigator:

Simon Tom, MD

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Kane O Pryor, MD

kap9009@med.cornell.edu

Michele L Steinkamp

mls9004@med.cornell.edu

Principal Investigator:

Kane O Pryor, MD

University of North Carolina School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Jay W Schoenherr, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Michael Manning, MD

michael.manning@duke.edu

Kelly Rodden, BSN

kelly.rodden@duke.edu

Principal Investigator:

Michael Manning, MD

Wake Forest

Recruiting

Winston-Salem, North Carolina, United States, 27109

Contacts

Principal Investigator:

Ashish Khanna, MD

Oregon Health and Sciences University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Michael Aziz, MD

azizm@ohsu.edu

Sarah Feller

fellersa@ohsu.edu

Principal Investigator:

Michael Aziz, MD

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Principal Investigator:

Sean Baskin, DO

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Kunal Karamchandani, MD

University of Texas - MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Juan Cata, MD

University of Utah - Medical

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Principal Investigator:

Rachel Danowit, MD

UVA Health

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Bhiken Naik, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Karen Domino, MD

kdomino@uw.edu

Sasha Luce

aluce1@uw.edu

Principal Investigator:

Karen Domino, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-09-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.