THRIVE Feasibility Trial

NCT ID: NCT05346588

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-29

Study Completion Date

2023-06-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Surgery--Complications Anesthesia Complication Anesthesia Awareness Anesthesia Emergence Delirium Anesthesia Surgery Quality of Life Pain, Postoperative Nausea, Postoperative Anesthesia Morbidity Depression Sleep Disorders, Circadian Rhythm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Propofol total intravenous anesthesia (TIVA)

No administration of inhaled agent.

Group Type ACTIVE_COMPARATOR

Anesthetic technique Propofol TIVA

Intervention Type OTHER

Propofol TIVA no inhaled agent

Inhaled volatile general anesthesia

Must administer inhaled agent.

Group Type ACTIVE_COMPARATOR

Anesthetic technique inhaled agent

Intervention Type OTHER

must administer inhaled agent.

Interventions

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Anesthetic technique Propofol TIVA

Propofol TIVA no inhaled agent

Intervention Type OTHER

Anesthetic technique inhaled agent

must administer inhaled agent.

Intervention Type OTHER

Other Intervention Names

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Propofol TIVA Inhaled agent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Michael Avidan

Prof of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sachin Kheterpal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Michael S Avidan, MBBcH

Role: PRINCIPAL_INVESTIGATOR

Washington Univeristy

Locations

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Stanford University

Stanford, California, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Hosptial of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Tellor Pennington BR, Colquhoun DA, Neuman MD, Politi MC, Janda AM, Spino C, Thelen-Perry S, Wu Z, Kumar SS, Gregory SH, Avidan MS, Kheterpal S; THRIVE research group. Feasibility pilot trial for the Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) pragmatic randomised controlled trial. BMJ Open. 2023 Apr 17;13(4):e070096. doi: 10.1136/bmjopen-2022-070096.

Reference Type DERIVED
PMID: 37068889 (View on PubMed)

Other Identifiers

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202205053

Identifier Type: -

Identifier Source: org_study_id