Status:
COMPLETED
THRIVE Feasibility Trial
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
University of Michigan
University of Pennsylvania
Conditions:
Surgery--Complications
Anesthesia Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
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 surger...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05346588
Start Date
September 29 2022
End Date
June 28 2023
Last Update
November 24 2023
Active Locations (4)
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1
Stanford University
Stanford, California, United States, 94305
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
Hosptial of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104