雷莫司琼预防腹腔镜胆囊切除术后恶心和呕吐:随机对照试验。

Yoshitaka Fujii, Aki Uemura, Hiroyoshi Tanaka
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引用次数: 29

摘要

目的:评价雷莫司琼(5-羟色胺3型受体拮抗剂)预防腹腔镜胆囊切除术后恶心呕吐的疗效和安全性。设计:前瞻性、随机、双盲、安慰剂对照研究。地点:日本大学及大学附属医院。对象:行腹腔镜胆囊切除术的100例患者,其中女性65例,男性35例。干预措施:患者在手术结束时静脉给予安慰剂或3种不同剂量的雷莫司琼(0.15 mg, 0.3 mg, 0.6 mg)。全麻技术及术后镇痛均符合标准。主要结局指标:麻醉后0 ~ 24小时和24 ~ 48小时评估呕吐和安全性。结果:麻醉后0 ~ 24小时内完全缓解(无恶心、无干呕、无呕吐)的患者人数为:安慰剂组15/25,雷莫司琼0.15 mg组17/25,雷莫司琼0.3 mg组23/25,雷莫司琼0.6 mg组23/25;24 ~ 48小时对应的数字分别为16、17、23、23。两组均未见严重不良事件发生。结论:腹腔镜胆囊切除术患者麻醉后0 ~ 48小时内预防术后恶心呕吐的最小有效剂量为雷莫司琼0.3 mg。
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Prophylaxis of nausea and vomiting after laparoscopic cholecystectomy with ramosetron: randomised controlled trial.

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.

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