THRIVE Feasibility Trial

Phase 3

Completed

• Conditions: Anesthesia Emergence Delirium; Anesthesia; Quality of Life; Pain, Postoperative; Depression; Anesthesia Morbidity; Sleep Disorders, Circadian Rhythm; Surgery--Complications; Anesthesia Complication; Anesthesia Awareness
• Interventions: Other: Anesthetic technique inhaled agent; Other: Anesthetic technique Propofol TIVA

• Registration Number: NCT05346588
• Lead Sponsor: Washington University School of Medicine

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 surgery. Patients will be stratified by clinical site with 150 participants per site.

Study Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-26
• Study Start: 2022-09-29
• Primary Completion: 2023-04-16
• Study Completion: 2023-06-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled volatile general anesthesia	Anesthetic technique inhaled agent	Must administer inhaled agent.
Propofol total intravenous anesthesia (TIVA)	Anesthetic technique Propofol TIVA	No administration of inhaled agent.

Primary Outcome Measures

Name	Time	Method
Proportion participating	8 months	Proportion of patients who are approached to participate by the study team and who consent to participate in the study.
Proportion receiving inhaled anesthesia	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).
Proportion receiving TIVA	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).

Secondary Outcome Measures

Name	Time	Method
Completeness of data collection	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)

Trial Locations

Locations (4)

Stanford University; 🇺🇸 Stanford, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Hosptial of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States