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左舒必利与雷莫司琼预防腹腔镜手术术后恶心呕吐的前瞻性随机双盲研究

Levosulpiride and Ramosetron for the Prevention of Postoperative Nausea and Vomiting in Laparoscopic Surgery: A Prospective Randomized Double-blind Study.

作者信息

Ranjithkumar R T, Sholapur Imran, Bhat Ravi, Kumar C Chandan

机构信息

S.D.M. College of Medical Sciences, Hospital and Research Center, Dharwad, Karnataka, India.

出版信息

Anesth Essays Res. 2022 Jul-Sep;16(3):307-310. doi: 10.4103/aer.aer_98_22. Epub 2022 Dec 9.

DOI:10.4103/aer.aer_98_22
PMID:36620113
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9813998/
Abstract

BACKGROUND

Postoperative nausea and vomiting (PONV) continues to be common complication of anesthesia and surgery in spite of availability of so many antiemetic drugs and regimens for prevention. This study compared Ramosetron and Levosulpiride in terms of efficacy for PONV prevention after laparoscopic surgery.

AIM

To compare the efficacy of intravenous (i.v.) Levosulpiride 25 mg with i.v. Ramosetron 0.3 mg in preventing PONV.

SETTING

S. D. M. College of Medical Sciences and Hospital, Sattur, Dharwad from November 2018 to June 2020.

DESIGN

It is a prospective randomized double-blind study.

STATISTICAL ANALYSIS

All the data were collected, tabulated, and expressed as mean ± standard deviation. Data were analyzed using IBM Statistical Package for the Social Sciences (SPSS 22.0 Evaluation version). Unpaired sample -test and Chi-square test have been used for the quantitative and qualitative data, respectively. A value of 0.05 was considered statistically insignificant.

MATERIALS AND METHODS

This prospective randomized, double-blind study was conducted in 200 patients undergoing laparoscopic surgery falling under the inclusion criteria are numbered and every nth patient selected by systemic random sampling procedure and allocated into two groups of 100 each, group Levosulpiride (Group L) and group Ramosetron (group R) study drugs givenwithin 30 min induction of anesthesia. Group L will receive LEVOSULPIRIDE 25 mg i.v. Group R will receive RAMOSETRON 0.3 mg i.v.

RESULTS

The incidence of vomiting in the Levosulpiride group and in the Ramosetron groupduring 0-4 h (20% vs. 30%, = 0.1110), 4-8 h (4% vs. 5%, = 0.7450), 8-12 h (5% vs. 4% = 0.7210) and 12-24 h (0% vs. 0%). The incidence of nausea and overall PONV and the use of rescue antiemetic was not significantly different during all time intervals. The severity of nausea was not different between the two groups. Difference in the efficacy of Levosulpiride and Ramosetron was statistically insignificant ( > 0.05) in the prevention of PONV.

CONCLUSION

Levosulpiride 25 mg or Ramosetron 0.3 mg given intravenously to prevent PONV inpatients undergoing elective laparoscopic surgery under general anesthesia are equally effective in controlling PONV.

摘要

背景

尽管有众多用于预防的止吐药物和方案,但术后恶心呕吐(PONV)仍是麻醉和手术常见的并发症。本研究比较了雷莫司琼和左舒必利预防腹腔镜手术后PONV的疗效。

目的

比较静脉注射25mg左舒必利与静脉注射0.3mg雷莫司琼预防PONV的疗效。

地点

2018年11月至2020年6月在达沃德萨特鲁的SDM医学科学与医院。

设计

这是一项前瞻性随机双盲研究。

统计分析

收集所有数据,列表并表示为均值±标准差。使用IBM社会科学统计软件包(SPSS 22.0评估版)进行数据分析。未配对样本t检验和卡方检验分别用于定量和定性数据。P值<0.05被认为具有统计学意义。

材料与方法

这项前瞻性随机双盲研究纳入了200例接受腹腔镜手术且符合纳入标准的患者,对其进行编号,通过系统随机抽样程序每隔n个患者选择1例,并分为两组,每组100例,即左舒必利组(L组)和雷莫司琼组(R组),在麻醉诱导后30分钟内给予研究药物。L组静脉注射25mg左舒必利,R组静脉注射0.3mg雷莫司琼。

结果

左舒必利组和雷莫司琼组在0 - 4小时(20%对30%,P = 0.1110)、4 - 8小时(4%对5%,P = 0.7450)、8 - 12小时(5%对4%,P = 0.7210)和12 - 24小时(0%对0%)的呕吐发生率。在所有时间段,恶心、总体PONV的发生率以及补救性止吐药的使用无显著差异。两组恶心的严重程度无差异。左舒必利和雷莫司琼在预防PONV方面的疗效差异无统计学意义(P>0.05)。

结论

对于接受全身麻醉的择期腹腔镜手术患者,静脉注射25mg左舒必利或0.3mg雷莫司琼预防PONV在控制PONV方面同样有效。

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本文引用的文献

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A randomized, double-blind study to evaluate the efficacy of ramosetron and palonosetron for prevention of postoperative nausea and vomiting after gynecological laparoscopic surgery.一项随机、双盲研究,旨在评估雷莫司琼和帕洛诺司琼预防妇科腹腔镜手术后恶心和呕吐的疗效。
Korean J Anesthesiol. 2013 Feb;64(2):133-7. doi: 10.4097/kjae.2013.64.2.133. Epub 2013 Feb 15.
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Ramosetron versus ondansetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy.雷莫司琼与昂丹司琼预防腹腔镜胆囊切除术后恶心呕吐的比较。
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Comparison of ramosetron with ondansetron for prevention of postoperative nausea and vomiting in patients undergoing gynaecological surgery.雷莫司琼与昂丹司琼预防妇科手术患者术后恶心呕吐的比较。
Br J Anaesth. 2009 Oct;103(4):549-53. doi: 10.1093/bja/aep209. Epub 2009 Aug 21.
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Consensus guidelines for managing postoperative nausea and vomiting.术后恶心呕吐管理的共识指南。
Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
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