Feasibility Pilot Trial for the Trajectories of Recovery after Intravenous Propofol versus Inhaled Volatile Anesthesia (THRIVE) Pragmatic Randomized Clinical Trial.

BACKGROUND

The Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anesthesia (THRIVE) trial is a multicenter prospective, randomized comparative effectiveness trial examining patients' experiences and outcomes after receiving either total intravenous anesthesia with propofol or inhaled volatile anesthesia for general anesthesia (NCT05991453). Before the 13,000-patient trial, a pilot trial (NCT05346588) was performed to establish feasibility and determine the percentage of success of (1) patient enrollment, (2) intervention adherence, and (3) data completion.

METHODS

This feasibility trial included adult patients undergoing elective noncardiac surgery requiring general anesthesia across two academic institutions in the United States. Patients were randomized to receive general anesthesia with total intravenous or inhalational anesthesia. Patients completed surveys on postoperative days 0, 1, 2, 7, 30, and 90. The percentages of consent, intervention adherence, and data completion were compared with predefined thresholds (10%, 80%, and 90%, respectively).

RESULTS

A total of 300 patients were enrolled across two sites: Washington University in St. Louis (St. Louis, Missouri) and the University of Michigan (Ann Arbor, Michigan), from September 2022 through March 2023. The percentages achieved significantly exceeded predefined thresholds: 351 of 663 (53%; 95% CI, 49 to 57%) patients approached were successfully consented, adherence to the randomized intervention occurred in 142 of 149 (95%; 95% CI, 92 to 99%) total intravenous anesthesia cases and 150 of 151 (99%; 95% CI, 98 to 100%) inhaled cases, and complete data collection occurred in 279 of 299 (93%; 95% CI, 91 to 96%) patients for the Quality of Recovery-15 and 299 of 299 (100% complete 95% CI, 100 to 100%) patients for the modified Brice, the intraoperative awareness screening questionnaire.

CONCLUSIONS

It was feasible to enroll sufficient patients, adhere strongly to the randomized treatment allocation, and obtain adequate outcomes data at these two pilot sites for the THRIVE trial.