THRIVE Feasibility Trial

Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05346588
Collaborator
University of Michigan (Other), University of Pennsylvania (Other), Stanford University (Other), Patient-Centered Outcomes Research Institute (Other)
300
4
2
14
75
5.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Anesthetic technique Propofol TIVA
  • Other: Anesthetic technique inhaled agent
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    Must administer inhaled agent.

    Other: Anesthetic technique inhaled agent
    must administer inhaled agent.
    Other Names:
  • Inhaled agent
  • Outcome Measures

    Primary Outcome Measures

    1. Proportion participating [8 months]

      Proportion of patients who are approached to participate by the study team and who consent to participate in the study.

    2. Proportion receiving TIVA [8 months]

      Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).

    3. Proportion receiving inhaled anesthesia [8 months]

      Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).

    Secondary Outcome Measures

    1. Completeness of data collection [11 months]

      Completeness of data collection (defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point and with each instrument)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 years or older

    • Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

    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 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 inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)

    • Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring).

    • Hospital approved, written protocol mandating a particular technique

    • History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent

    • Planned postoperative intubation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305
    2 University of Michigan Ann Arbor Michigan United States 48109
    3 Washington University School of Medicine Saint Louis Missouri United States 63110
    4 Hosptial of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Washington University School of Medicine
    • University of Michigan
    • University of Pennsylvania
    • Stanford University
    • Patient-Centered Outcomes Research Institute

    Investigators

    • Principal Investigator: Sachin Kheterpal, MD, University of Michigan
    • Principal Investigator: Michael S Avidan, MBBcH, Washington Univeristy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Avidan, Prof of Anesthesiology, Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05346588
    Other Study ID Numbers:
    • 202203MSA
    First Posted:
    Apr 26, 2022
    Last Update Posted:
    Apr 26, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael Avidan, Prof of Anesthesiology, Washington University School of Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 26, 2022