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). Prior to the 13,000-patient trial, a pilot trial (NCT05346588) was performed to establish feasibility and determine percent success of: 1) patient enrollment, 2) intervention adherence, and 3) data completion. Methods: We conducted a feasibility trial including adult patients undergoing elective non-cardiac 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. Percentages of consent, intervention adherence, and data completion were compared with pre-defined thresholds (10%, 80%, and 90%, respectively). Results: 300 patients were enrolled across two sites, Washington University in St. Louis and the University of Michigan, from September, 2022 through March, 2023. The percentages achieved significantly exceeded pre-defined 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 for the Quality of Recovery-15 in 279 of 299 (93%, 95% CI, 91% to 96%) patients 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.