drugset / Trial / NCT00878228
Antiemetic Prophylaxis for Postdischarge Nausea and Vomiting After Hip Arthroscopy
RandomizedParallel-groupDouble-blindTreatment
Summary
The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).
Timeline
- Start
- 2009-04
- Primary completion
- 2010-01
- Completion
- 2010-02
Publications
- Background Osoba D, Zee B, Warr D, Latreille J, Kaizer L, Pater J. Effect of postchemotherapy nausea and vomiting on health-related quality of life. The Quality of Life and Symptom Control Committees of the National Cancer Institute of Canada Clinical Trials Group. Support Care Cancer. 1997 Jul;5(4):307-13. doi: 10.1007/s005200050078.
- Background Pan PH, Lee SC, Harris LC. Antiemetic prophylaxis for postdischarge nausea and vomiting and impact on functional quality of living during recovery in patients with high emetic risks: a prospective, randomized, double-blind comparison of two prophylactic antiemetic regimens. Anesth Analg. 2008 Aug;107(2):429-38. doi: 10.1213/ane.0b013e318172f992.
- Background Gan TJ, Meyer TA, Apfel CC, Chung F, Davis PJ, Habib AS, Hooper VD, Kovac AL, Kranke P, Myles P, Philip BK, Samsa G, Sessler DI, Temo J, Tramer MR, Vander Kolk C, Watcha M; Society for Ambulatory Anesthesia. Society for Ambulatory Anesthesia guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2007 Dec;105(6):1615-28, table of contents. doi: 10.1213/01.ane.0000295230.55439.f4.
- Background Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.
- Background White PF, O'Hara JF, Roberson CR, Wender RH, Candiotti KA; POST-OP Study Group. The impact of current antiemetic practices on patient outcomes: a prospective study on high-risk patients. Anesth Analg. 2008 Aug;107(2):452-8. doi: 10.1213/ane.0b013e31817b842c.
- Background White PF, Sacan O, Nuangchamnong N, Sun T, Eng MR. The relationship between patient risk factors and early versus late postoperative emetic symptoms. Anesth Analg. 2008 Aug;107(2):459-63. doi: 10.1213/ane.0b013e31817aa6e4.
- Background Pavlin DJ, Chen C, Penaloza DA, Polissar NL, Buckley FP. Pain as a factor complicating recovery and discharge after ambulatory surgery. Anesth Analg. 2002 Sep;95(3):627-34, table of contents. doi: 10.1097/00000539-200209000-00025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ondansetron | Other / unclassified | 8 mg | Intravenous |
Indications
No indication recorded.