부인과 수술 후 오심 및 구토 예방을 위한 Ramosetron의 적정 용량 연구 = The Optimal Anti-Emetic Dose of Ramosetron for the Prevention of Postoperative Nausea and Vomiting after Gynecolgic Surgery

다국어 초록 (Multilingual Abstract)

Postoperative nausea and vomiting (PONV) is one of the most frequent and distressing side effects of surgery, and approximately 50−70% of patients who undergo gynecologic surgery suffer from PONV. In this study, we evaluated the effects of various doses of ramosetron on postoperative nausea and vomiting following gynecologic surgery.
Methods: This study evaluated a randomized placebo-controlled study comprised of 200 patients who underwent gynecologic surgery under general anesthesia. The patients were divided into the following 4 groups; placebo group (saline 4 ml), R15 group (ramosetron 0.15 mg), R30 group (ramosetron 0.3 mg) and R45 group (ramosetron 0.45 mg). Each patient was administered the study drug intravenously at the completion of the operation and the presence and severity of PONV were then evaluated 24 and 48 hours after the operation.
Results: The incidence of PONV during the first 24 hours following surgery was lower in patients in the R30 group (44%) than in patients in the placebo group (68%)(P ＜ 0.05). In addition, the incidence of PONV 24 to 48 hours after the operation was lower in patients in the R30 group (12%) and the R45 group (14%) than in patients in the placebo group (44%)(P ＜ 0.05) Moreover, common side effects of 5-HT3 receptor antagonist such as headache, dizziness, and constipation did not develop in any of the groups.
Conclusions: The results of this study indicate that 0.3 mg of ramosetron is the most effective dose for preventing PONV during to the first 48 hours following gynecologic surgery.

다국어 초록 (Multilingual Abstract)

Postoperative nausea and vomiting (PONV) is one of the most frequent and distressing side effects of surgery, and approximately 50−70% of patients who undergo gynecologic surgery suffer from PONV. In this study, we evaluated the effects of various doses of ramosetron on postoperative nausea and vomiting following gynecologic surgery.
Methods: This study evaluated a randomized placebo-controlled study comprised of 200 patients who underwent gynecologic surgery under general anesthesia. The patients were divided into the following 4 groups; placebo group (saline 4 ml), R15 group (ramosetron 0.15 mg), R30 group (ramosetron 0.3 mg) and R45 group (ramosetron 0.45 mg). Each patient was administered the study drug intravenously at the completion of the operation and the presence and severity of PONV were then evaluated 24 and 48 hours after the operation.
Results: The incidence of PONV during the first 24 hours following surgery was lower in patients in the R30 group (44%) than in patients in the placebo group (68%)(P ＜ 0.05). In addition, the incidence of PONV 24 to 48 hours after the operation was lower in patients in the R30 group (12%) and the R45 group (14%) than in patients in the placebo group (44%)(P ＜ 0.05) Moreover, common side effects of 5-HT3 receptor antagonist such as headache, dizziness, and constipation did not develop in any of the groups.
Conclusions: The results of this study indicate that 0.3 mg of ramosetron is the most effective dose for preventing PONV during to the first 48 hours following gynecologic surgery.

참고문헌 (Reference)

1 Macario A, "Which clinical anesthesia outcomes are important to avoid? The perspective of patients" 89 : 652-658, 1999

2 Apfel CC, "Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design" 88 : 659-668, 2002

3 Gan TJ, "Risk factors for postoperative nausea and vomiting" 102 : 1884-1898, 2006

4 Fujii Y, "Randomized, double-blind, placebo-controlled, dosed-finding study of the antiemetic effects and tolerability of ramosetron in adults undergoing middle ear surgery" 25 : 3100-3108, 2003

5 Shi Y, "Ramosetron versus ondansetron in the prevention of chemotherapy-induced gastrointestinal side effects: a prospective randomized controlled study" 53 : 44-50, 2007

6 Kang YK, "Ramosetron for the prevention of cisplatin-induced acute emesis: a prospective randomized comparison with granisetron" 30 : 220-229, 2002

7 Fujii Y, "Ramosetron for preventing postoperative nausea and vomiting in women undergoing gynecological surgery" 90 : 472-475, 2000

8 Fujii Y, "Prophylaxis of nausea and vomiting after laparoscopic cholecystectomy with ramosetron: randomised controlled trial" 168 : 583-586, 2002

9 Kovac A, "Prophylactic intravenous ondansetron in female outpatients undergoing gynaecological surgery: a multicentre dose-comparison study" 6 : 37-47, 1992

10 Golembiewski J, "Prevention and treatment of postoperative nausea and vomiting" 62 : 1247-1260, 2005

11 Gan TJ, "Postoperative nausea and vomiting: can it be eliminated?" 287 : 1233-1236, 2002

12 Watcha MF, "Postoperative nausea and vomiting. Its etiology, treatment, and prevention" 77 : 162-184, 1992

13 Watcha MF, "Postoperative nausea and emesis" 20 : 709-722, 2002

14 Apfel CC, "How to study postoperative nausea and vomiting" 46 : 921-928, 2002

15 Fujii Y, "Double-blind, placebo-controlled, dose-ranging study of ramosetron for the prevention of nausea and vomiting after thyroidectomy" 24 : 1148-1153, 2002

16 Eberhart LH, "Dimenhydrinate and metoclopramide alone or in combination for prophylaxis of PONV" 47 : 780-785, 2000

17 Gan TJ, "Consensus guidelines for managing postoperative nausea and vomiting" 97 : 62-71, 2003

18 Fujii Y, "Comparison of ramosetron and granisetron for preventing postoperative nausea and vomiting after gynecologic surgery" 89 : 476-479, 1999

19 Apfel CC, "Comparison of predictive models for postoperative nausea and vomiting" 88 : 234-240, 2002

20 .McKenzie R, "Comparison of ondansetron versus placebo to prevent postoperative nausea and vomiting in women undergoing ambulatory gynecologic surgery" 78 : 21-28, 1993

21 Sinclair DR, "Can postoperative nausea and vomiting be predicted?" 91 : 109-118, 1999

22 Koivuranta M, "A survey of postoperative nausea and vomiting" 52 : 443-449, 1997

23 Apfel CC, "A simplified risk score for predicting postoperative nausea and vomiting" 91 : 693-700, 1999

24 Tramer MR, "A quantitative systematic review of ondansetron in treatment of established postoperative nausea and vomiting" 314 : 1088-1092, 1997