Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
THRIVE
1 other identifier
interventional
13,000
1 country
20
Brief Summary
The investigators will conduct a 13,000-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
August 5, 2025
July 1, 2025
3.9 years
June 23, 2023
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Postoperative day 1
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Postoperative day 1
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Postoperative day 1
Incidence of definite intraoperative awareness with recall
The modified Brice questionnaire is used to screen for intraoperative awareness. A positive screen (a patient who reports remembering anything between going to sleep for their surgical procedure and waking up after) on the modified Brice questionnaire is followed by a structured interview. A panel of expert adjudicators determines whether or not this was definite intraoperative awareness.
Postoperative day 30
Secondary Outcomes (56)
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery
postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery
postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery
postoperative day 0
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery
postoperative day 2
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery
postoperative day 2
- +51 more secondary outcomes
Other Outcomes (63)
Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery.
1 - 7 days prior to surgery
Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
1 - 7 days prior to surgery
Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery.
1 - 7 days prior to surgery
- +60 more other outcomes
Study Arms (2)
Propofol total intravenous anesthesia (TIVA)
ACTIVE COMPARATORNo administration of inhaled agent.
inhaled volatile general anesthesia (INVA)
ACTIVE COMPARATORMust administer inhaled agent.
Interventions
Propofol TIVA no inhaled agent
Must administer inhaled agent.
Eligibility Criteria
You may qualify if:
- Each patient must meet all of the following criteria:
- Aged 18 years or older
- Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device)
You may not qualify if:
- Patients will not be enrolled if any of the following criteria are met:
- Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
- 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 INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report
- Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
- Locally approved, written protocol mandating a particular anesthetic technique
- History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
- Planned postoperative intubation
- Current incarceration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Patient-Centered Outcomes Research Institutecollaborator
- University of Michigancollaborator
Study Sites (20)
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205, United States
University of California San Francisco
San Francisco, California, 94143, United States
Stanford University
Stanford, California, 94305, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NYU Langone
New York, New York, 10012, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27708, United States
Wake Forest
Winston-Salem, North Carolina, 27109, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Texas - MD Anderson
Houston, Texas, 77030, United States
University of Utah - Medical
Salt Lake City, Utah, 84132, United States
UVA Health
Charlottesville, Virginia, 22908, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Tellor Pennington BR, Janda AM, Colquhoun DA, Neuman MD, Kidwell KM, Spino C, Thelen-Perry S, Krambrink A, Huang S, Ignacio R, Wu Z, Swisher L, Cloyd C, Vaughn MT, Pescatore NA, Bollini ML, Mashour GA, Hassett A, Kent CD, Vlisides PE, Avidan MS, Kheterpal S; Ë THRIVE Research Group. Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol. BMJ Open. 2025 Sep 14;15(9):e103836. doi: 10.1136/bmjopen-2025-103836.
PMID: 40953862DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sachin Kheterpal, MD
University of Michigan
- PRINCIPAL INVESTIGATOR
Michael S Avidan, MBBCh
Washington University School of Medicine
- STUDY DIRECTOR
Allison Janda, MD
University of Michigan
- STUDY DIRECTOR
Mark Neuman, MD
University of Pennsylvania
- STUDY DIRECTOR
Bethany Pennington, PharmD
Washington University School of Medicine
- STUDY DIRECTOR
Douglas Colquhoun, MBChB
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
June 23, 2023
First Posted
August 14, 2023
Study Start
September 13, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2028
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data package will be transferred to the data repository by October 1, 2028, per the contract with PCORI.
- Access Criteria
- PCORI's access criteria and data sharing policy for third parties can be found here https://www.pcori.org/sites/default/files/PCORI-Policy-for-Data-Management-and-Data-Sharing.pdf
Per the contract with the funder PCORI, the THRIVE Data Sharing Plan will be consistent with PCORI's Policy for Data Management and Data Sharing, which calls for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. THRIVE will upload a deidentified dataset to the Patient-Centered Outcomes Data Repository (PCODR), which was created and is hosted by the Inter-University Consortium for Political and Social Research (ICPSR), a unit within the Institute for Social Research at the University of Michigan. The THRIVE study, as the Awardee, will enter into a Data Contributor Agreement (DCA) with ICPSR. The DCA governs the data deposition and establishes the Awardee's rights and obligations. The data package will be transferred to the data repository by October 1, 2028, per the contract with PCORI.