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雷莫司琼预防腹腔镜胆囊切除术后恶心呕吐的随机对照试验。

Prophylaxis of nausea and vomiting after laparoscopic cholecystectomy with ramosetron: randomised controlled trial.

作者信息

Fujii Yoshitaka, Uemura Aki, Tanaka Hiroyoshi

机构信息

Department of Anaesthesiology, University of Tsukuba Institute of Clinical Medicine, Tsukuba City, Ibaraki, Japan.

出版信息

Eur J Surg. 2002;168(11):583-6. doi: 10.1080/11024150201680002.

DOI:10.1080/11024150201680002
PMID:12699092
Abstract

OBJECTIVE

To evaluate the efficacy and safety of ramosetron (a 5-hydroxytryptamine type 3 receptor antagonist) for the prevention of nausea and vomiting after laparoscopic cholecystectomy.

DESIGN

Prospective, randomised, double-blind, placebo-controlled study.

SETTING

University and university-affiliated hospitals, Japan.

SUBJECTS

100 patients, 65 women and 35 men, who had laparoscopic cholecystectomy.

INTERVENTIONS

Patients were given either placebo or ramosetron at 3 different doses (0.15 mg, 0.3 mg, 0.6 mg) intravenously at the completion of operation. The general anaesthetic technique and postoperative analgesia were standard.

MAIN OUTCOME MEASURES

Vomiting and safety were assessed for 0 to 24 hours and 24 to 48 hours after anaesthesia.

RESULTS

The number of patients who had a complete response (no nausea, no retching, no vomiting) during 0 to 24 hours after anaesthesia was 15/25 with placebo, 17/25 with ramosetron 0.15 mg, 23/25 with ramosetron 0.3 mg, and 23/25 with ramosetron 0.6 mg; The corresponding numbers from 24 to 48 hours were 16, 17, 23, and 23. No serious adverse events were observed in any of the groups.

CONCLUSIONS

Ramosetron 0.3 mg was the minimum effective dose for preventing postoperative nausea and vomiting during 0 to 48 hours after anaesthesia in patients undergoing laparoscopic cholecystectomy.

摘要

目的

评估雷莫司琼(一种5-羟色胺3型受体拮抗剂)预防腹腔镜胆囊切除术后恶心和呕吐的疗效及安全性。

设计

前瞻性、随机、双盲、安慰剂对照研究。

地点

日本的大学及大学附属医院。

研究对象

100例行腹腔镜胆囊切除术的患者,其中女性65例,男性35例。

干预措施

手术结束时,患者静脉注射安慰剂或3种不同剂量(0.15毫克、0.3毫克、0.6毫克)的雷莫司琼。全身麻醉技术和术后镇痛均为标准操作。

主要观察指标

在麻醉后0至24小时以及24至48小时评估呕吐情况及安全性。

结果

麻醉后0至24小时内完全缓解(无恶心、无干呕、无呕吐)的患者数量,安慰剂组为15/25,雷莫司琼0.15毫克组为17/25,雷莫司琼0.3毫克组为23/25,雷莫司琼0.6毫克组为23/25;24至48小时的相应数字分别为16、17、23和

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