Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05991453

Trajectories of Recovery After Intravenous Propofol Versus Inhaled Volatile Anesthesia Trial

Led by Washington University School of Medicine · Updated on 2025-08-05

13000

Participants Needed

20

Research Sites

52 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a large randomized trial with 13,000 patients to compare two types of general anesthesia techniques: intravenous propofol total intravenous anesthesia (TIVA) and inhaled volatile general anesthesia (INVA). The study focuses on patients undergoing major inpatient, minor inpatient, or outpatient surgeries lasting at least 60 minutes. It aims to identify which anesthesia method leads to better patient recovery experiences and to assess whether TIVA increases the risk of intraoperative awareness compared to INVA. Participants will be randomly assigned to receive either propofol TIVA without inhaled agents or inhaled volatile anesthesia during their surgery. Both techniques require general anesthesia with airway management using a tracheal tube or laryngeal mask airway. The trial includes various surgical categories, and patients will be monitored throughout their perioperative period to evaluate recovery outcomes and safety. During the study, patients' recovery quality will be measured using the Patient Reported Quality of Recovery-15 (QOR15) score on postoperative days 0, 1, 2, and 7, depending on the surgery type. Additional assessments include incidence of intraoperative awareness, delirium, functional status, health-related quality of life, patient satisfaction, and other safety outcomes up to one year after surgery. The trial's follow-up extends through postoperative day 365 to comprehensively assess recovery and complications.

CONDITIONS

Brief Title

Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Undergoing elective non-cardiac surgery expected to last at least 60 minutes
  • Surgery requires general anesthesia with a tracheal tube or laryngeal mask airway or similar device
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent in English or Spanish
  • Pregnant based on patient report or positive test on surgery day
  • Surgery requiring general, regional, or neuraxial anesthesia within 30 days before or after the planned surgery
  • Contraindication to propofol TIVA or inhaled anesthesia such as allergy or history of severe nausea, vomiting, or malignant hyperthermia
  • Surgery requiring a specific anesthesia technique (e.g., TIVA for neuromonitoring)
  • Written protocol mandating a particular anesthesia technique
  • History of possible or definite intraoperative awareness during general anesthesia
  • Planned postoperative intubation
  • Current incarceration

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of surgery (at least 60 minutes)

Participants receive either intravenous propofol anesthesia or inhaled volatile anesthesia during their elective non-cardiac surgery.

1 surgery day visit

Post-operative Follow-up

Duration - Up to 365 days after surgery

Participants are monitored for recovery and assessed for quality of recovery, delirium, functional status, and other health outcomes after surgery.

Multiple visits including postoperative days 0, 1, 2, 7, 30, 90, 180, and 365

Trial Site Locations

Total: 20 locations

1

University of Arkansas for Medical Sciences (UAMS)

Little Rock, Arkansas, United States, 72205

Actively Recruiting

2

University of California San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

3

Stanford University

Stanford, California, United States, 94305

Not Yet Recruiting

4

Yale School of Medicine

New Haven, Connecticut, United States, 06510

Actively Recruiting

5

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

6

Brigham & Women's

Boston, Massachusetts, United States, 02115

Actively Recruiting

7

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

8

Henry Ford Health

Detroit, Michigan, United States, 48202

Actively Recruiting

9

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

10

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

11

NYU Langone

New York, New York, United States, 10012

Actively Recruiting

12

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

13

Duke University

Durham, North Carolina, United States, 27708

Actively Recruiting

14

Wake Forest

Winston-Salem, North Carolina, United States, 27109

Actively Recruiting

15

Oregon Health and Sciences University

Portland, Oregon, United States, 97239

Actively Recruiting

16

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Not Yet Recruiting

17

University of Texas - MD Anderson

Houston, Texas, United States, 77030

Actively Recruiting

18

University of Utah - Medical

Salt Lake City, Utah, United States, 84132

Actively Recruiting

19

UVA Health

Charlottesville, Virginia, United States, 22908

Actively Recruiting

20

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

L

Laura Swisher

S

Sherry McKinnon

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol.

Bethany R Tellor Pennington, Allison M Janda, Douglas A Colquhoun...

https://pubmed.ncbi.nlm.nih.gov/40953862