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[昂丹司琼用于预防术后恶心和呕吐。与氟哌利多的前瞻性随机双盲对照研究]

[Ondansetron as prophylaxis for postoperative nausea and vomiting. A prospective randomized double-blind comparative study with droperidol].

作者信息

Alon E, Biro P, Lenzlinger P M, Atanassoff P G

机构信息

Institut für Anästhesiologie, Universitätsspital Zürich.

出版信息

Anaesthesist. 1994 Aug;43(8):500-3. doi: 10.1007/s001010050084.

Abstract

Ondansetron, a selective 5-HT3 receptor antagonist, has recently been shown, in a dose of 8 mg, to be superior to 1.25 mg droperidol in preventing postoperative vomiting. There are indications that a dose of 4 mg of ondansetron may be just as effective in reducing postoperative nausea and vomiting as a dose of 8 mg. The aim of this study was to evaluate the efficacy and the adverse effects of 4 mg ondansetron in the prevention of postoperative nausea and vomiting compared to droperidol in patients undergoing surgery with inhalation anaesthesia supplemented with alfentanil. METHODS. Following institutional approval, 40 ASA physical status I and II women scheduled for minor gynaecological surgery gave informed consent to participate in this randomized, double-blind comparative study. Five minutes before induction of general anaesthesia, 20 patients received a single intravenous (i.v.) dose of 4 mg of ondansetron and the remaining 20 received 1.25 mg droperidol i.v. Anaesthesia was induced with 2.1-4 mg/kg of thiopental and 0.1 mg of alfentanil i.v. and maintained with 65% nitrous oxide and 1.5%-3% enflurane in oxygen. On pain stimuli another 0.2-0.4 mg of alfentanil was given. Total effective antiemetic response was defined as the absence of nausea and vomiting for 24 h postoperatively. The incidence of nausea, vomiting and the number of patients showing total antiemetic response as well as the incidence of adverse effects were compared with the chi 2 test and P < 0.05 was considered significant. RESULTS. Patients were similar with respect to age, height, body weight and total anaesthetic agents received. Duration of anaesthesia and the time until awakening was not significantly different among groups. Postoperatively 7 out of 20 patients given 4 mg of ondansetron and 3 out of 20 patients with droperidol vomited (n.s.). The incidence of nausea was 11 out of 20 in the ondansetron group, and 4 out of 20 in the droperidol group (P < 0.05). Sixteen patients in the droperidol group and 8 patients in the ondansetron group showed a total effective antiemetic response (P < 0.05). Postoperative sedation and well-being scores did not differ significantly among groups. CONCLUSION. Our results show that for the prevention of postoperative nausea and vomiting 4 mg of Ondansetron was inferior to 1.25 mg of droperidol. The drugs were given intravenously prior to general anaesthesia for minor gynaecological surgery with nitrous oxide and enflurane in oxygen supplemented with small boluses of alfentanil.

摘要

昂丹司琼是一种选择性5-羟色胺3(5-HT3)受体拮抗剂,最近研究表明,8毫克剂量的昂丹司琼在预防术后呕吐方面优于1.25毫克氟哌利多。有迹象表明,4毫克剂量的昂丹司琼在减少术后恶心和呕吐方面可能与8毫克剂量同样有效。本研究的目的是评估在接受吸入麻醉并辅以阿芬太尼的手术患者中,4毫克昂丹司琼与氟哌利多相比在预防术后恶心和呕吐方面的疗效及不良反应。方法:经机构批准后,40例拟行小型妇科手术的美国麻醉医师协会(ASA)身体状况I级和II级的女性患者签署知情同意书,参与这项随机、双盲对照研究。在全身麻醉诱导前5分钟,20例患者静脉注射单次剂量4毫克的昂丹司琼,其余20例静脉注射1.25毫克氟哌利多。用2.1 - 4毫克/千克硫喷妥钠和0.1毫克阿芬太尼静脉诱导麻醉,并用65%氧化亚氮和1.5% - 3%安氟醚加氧气维持麻醉。在疼痛刺激时,再给予0.2 - 0.4毫克阿芬太尼。总有效止吐反应定义为术后24小时无恶心和呕吐。恶心、呕吐的发生率、出现总止吐反应的患者数量以及不良反应的发生率采用卡方检验进行比较,P<0.05被认为具有统计学意义。结果:患者在年龄、身高、体重以及接受的总麻醉药物方面相似。各组间麻醉持续时间和苏醒时间无显著差异。术后,接受4毫克昂丹司琼的20例患者中有7例呕吐,接受氟哌利多的20例患者中有3例呕吐(无统计学差异)。昂丹司琼组恶心发生率为20例中的11例,氟哌利多组为20例中的4例(P<0.05)。氟哌利多组16例患者和昂丹司琼组8例患者显示出总有效止吐反应(P<0.05)。各组间术后镇静和舒适评分无显著差异。结论:我们的结果表明,对于预防术后恶心和呕吐,4毫克昂丹司琼不如1.25毫克氟哌利多。这些药物在全身麻醉前静脉注射,用于小型妇科手术,麻醉采用氧化亚氮和安氟醚加氧气,并辅以小剂量阿芬太尼。

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