drugset / Trial / NCT06997419
Dexamethasone Palmitate for PONV After Open Surgery
RandomizedParallel-groupOpen-labelPrevention
Summary
Dexamethasone is almost one of the most commonly used drugs for postoperative nausea and vomiting (PONV) prevention. However, PONV is still a complex problem to be solved; for example, even with preoperative dexamethasone administration, there are still some patients still experience PONV within 24 hours postoperatively. Compared to dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, 2-5 times that of traditional water-soluble dexamethasone, with fewer adverse effects. This trial aims to assess the effect and safety of preoperative dexamethasone palmitate on PONV after open surgery.
Timeline
- Start
- 2025-07-01
- Primary completion
- 2026-11-30
- Completion
- 2026-12-31
Publications
- Background Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Background Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.
- Background Gan TJ. Risk factors for postoperative nausea and vomiting. Anesth Analg. 2006 Jun;102(6):1884-98. doi: 10.1213/01.ANE.0000219597.16143.4D.
- Background Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.
- Background Hahm TS, Ko JS, Choi SJ, Gwak MS. Comparison of the prophylactic anti-emetic efficacy of ramosetron and ondansetron in patients at high-risk for postoperative nausea and vomiting after total knee replacement. Anaesthesia. 2010 May;65(5):500-4. doi: 10.1111/j.1365-2044.2010.06310.x. Epub 2010 Mar 19.
- Background Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. doi: 10.1185/030079906X104830.
- Background Rwei AY, Sherburne RT, Zurakowski D, Wang B, Kohane DS. Prolonged Duration Local Anesthesia Using Liposomal Bupivacaine Combined With Liposomal Dexamethasone and Dexmedetomidine. Anesth Analg. 2018 Apr;126(4):1170-1175. doi: 10.1213/ANE.0000000000002719.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 5 mg | Intravenous |
| Subject | Dexamethasone Palmitate | Other / unclassified | 8 mg | Intravenous |
Indications
No indication recorded.