THRIVE Feasibility Trial

Last updated: November 22, 2023
Sponsor: Washington University School of Medicine
Overall Status: Completed

Phase

3

Condition

Surgery

Depression

Narcolepsy

Treatment

Anesthetic technique inhaled agent

Anesthetic technique Propofol TIVA

Clinical Study ID

NCT05346588
202205053
  • Ages > 18
  • All Genders

Study Summary

To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older
  • Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring generalanesthesia, including a tracheal tube or laryngeal mask airway (or similarsupra-glottic device)

Exclusion

Exclusion Criteria:

  • Inability to provide informed consent in English
  • Pregnancy (based on patient report or positive test on the day of surgery)
  • Surgical procedure requiring general, regional, neuraxial anesthesia administered byan anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurringwithin 30 days prior to or planned to occur within 30 days after surgery date
  • Contraindication to propofol TIVA or inhaled volatile (for example, documented allergyto propofol, history of severe postoperative nausea or vomiting, concern for orhistory of malignant hyperthermia)
  • Surgical procedures requiring specific general anesthesia option (for example, TIVArequired for neuromonitoring).
  • Hospital approved, written protocol mandating a particular technique
  • History of intraoperative awareness during general anesthesia based on patientself-report on the day of consent
  • Planned postoperative intubation

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Anesthetic technique inhaled agent
Phase: 3
Study Start date:
September 29, 2022
Estimated Completion Date:
June 28, 2023

Study Description

Two-center single-blinded randomized feasibility study, with randomization 1:1 to either propofol TIVA or inhaled volatile general anesthesia for patients who are receiving elective non-cardiac surgery. Patients will be stratified by clinical site with 150 participants per site.

Connect with a study center

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Hosptial of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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