Study Results
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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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2022-09-29
2023-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Propofol total intravenous anesthesia (TIVA)
No administration of inhaled agent.
Anesthetic technique Propofol TIVA
Propofol TIVA no inhaled agent
Inhaled volatile general anesthesia
Must administer inhaled agent.
Anesthetic technique inhaled agent
must administer inhaled agent.
Interventions
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Anesthetic technique Propofol TIVA
Propofol TIVA no inhaled agent
Anesthetic technique inhaled agent
must administer inhaled agent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
University of Pennsylvania
OTHER
Stanford University
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Michael Avidan
Prof of Anesthesiology
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
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hosptial of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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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.
Other Identifiers
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202205053
Identifier Type: -
Identifier Source: org_study_id