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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

ArmDescriptionAssigned Intervention
Active Comparator
Propofol total intravenous anesthesia (TIVA) 		No administration of inhaled agent.
  • Other: Anesthetic technique Propofol TIVA
    Propofol TIVA no inhaled agent
    Other names:
    • Propofol TIVA
Active Comparator
inhaled volatile general anesthesia (INVA) 		Must administer inhaled agent.
  • Other: Anesthetic technique inhaled agent
    Must administer inhaled agent.
    Other names:
    • Inhaled agent

Recruiting Locations

University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas 72205
Contact:
Geoffrey Muller, MD
gdmuller@uams.edu

University of California San Francisco
San Francisco, California 94143
Contact:
Lee-lynn Chen, MD
lee-lynn.chen@ucsf.edu

Yale School of Medicine
New Haven, Connecticut 06510
Contact:
Jaime B Hyman, MD
jaime.hyman@yale.edu

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Amit Bardia, MD
abardia@mgb.org

Brigham & Women's
Boston, Massachusetts 02115
Contact:
Luigino Nascimben, MD
lnascimben@bwh.harvard.edu

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Allison Janda, MD
ajanda@med.umich.edu

Henry Ford Health
Detroit, Michigan 48202
Contact:
Anoop Chhina, MD
achhina1@hfhs.org

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Laura Swisher
goodl@wustl.edu

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Stacie Deiner, MD
Stacie.G.Deiner@Hitchcock.org

NYU Langone
New York, New York 10012
Contact:
Simon Tom, MD
Simon.Tom@nyulangone.org

Weill Cornell Medicine
New York, New York 10065
Contact:
Kane O Pryor, MD
kap9009@med.cornell.edu

Duke University
Durham, North Carolina 27708
Contact:
Kam Ghadimi, MD
kamrouz.Ghadimi@duke.edu

Wake Forest
Winston-Salem, North Carolina 27109
Contact:
Ashish Khanna, MD
akhanna@wakehealth.edu

Oregon Health and Sciences University
Portland, Oregon 97239
Contact:
Michael Aziz, MD
azizm@ohsu.edu

University of Texas - MD Anderson
Houston, Texas 77030
Contact:
Juan Cata, MD
jcata@mdanderson.org

University of Utah - Medical
Salt Lake City, Utah 84132
Contact:
Ken Johnson, MD
ken.b.johnson@hsc.utah.edu

UVA Health
Charlottesville, Virginia 22908
Contact:
Bhiken Naik, MD
bin4n@uvahealth.org

University of Washington
Seattle, Washington 98195
Contact:
Karen Domino, MD
kdomino@uw.edu

More Details

NCT ID
NCT05991453
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Laura Swisher
314-286-1024
goodl@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.