THRIVE Feasibility Trial (THRIVE)

May 23, 2023 updated by: Michael Avidan, Washington University School of Medicine

Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hosptial of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion participating
Time Frame: 8 months
Proportion of patients who are approached to participate by the study team and who consent to participate in the study.
8 months
Proportion receiving TIVA
Time Frame: 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).
8 months
Proportion receiving inhaled anesthesia
Time Frame: 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).
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of data collection
Time Frame: 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)
11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Patient-Centered Outcomes Research Institute
University of Pennsylvania
University of Michigan
Stanford University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Actual)

April 27, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202205053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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