drugset / Trial / NCT05676294
The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge From Ambulatory Surgery
RandomizedParallel-groupTriple-blindSupportive care
Summary
The primary objective of this phase 2 randomized controlled trial is to determine whether the pre-operative administration of olanzapine (5 mg PO) improves quality of recovery (assessed by the Quality of Recovery-40 (QoR-40) survey) on postoperative day 1 in patients having ambulatory surgery with general anesthesia. The secondary objectives of this study are to determine whether there are differences in quality of recovery on postoperative day 2, presence of post-discharge nausea, presence of severe post-discharge nausea, recovery room length of stay and opioid consumption in patients who receive the study drug versus placebo.
Timeline
- Start
- 2023-06-26
- Primary completion
- 2025-12-05
- Completion
- 2025-12-06
Publications
- Background Hyman JB, Park C, Lin HM, Cole B, Rosen L, Fenske SS, Barr Grzesh RL, Blank SV, Polsky SB, Hartnett M, Taub PJ, Palvia V, DeMaria S Jr, Ascher-Walsh C. Olanzapine for the Prevention of Postdischarge Nausea and Vomiting after Ambulatory Surgery: A Randomized Controlled Trial. Anesthesiology. 2020 Jun;132(6):1419-1428. doi: 10.1097/ALN.0000000000003286.
- Guzzi J, Gugel T, Fernandez Robles C, Herrera A, Zhao X, Shapiro A, Fernandez T, Longley M, Stephan A, Nguyen HP, Valedon A, Tanaka C, Belkasim S, Gilmore ML, Lin HM, Hyman JB. Preoperative Olanzapine and Quality of Recovery after Ambulatory Surgery: A Randomized Clinical Trial. Anesthesiology. 2026 May 20. doi: 10.1097/ALN.0000000000006166. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olanzapine | Small molecule | 5 mg | Oral |
Indications
No indication recorded.