评估按体重调整剂量的帕洛诺司琼预防日间腹腔镜妇科手术术后恶心和呕吐的效果：一项剂量范围随机对照试验。

Evaluation of weight-adjusted doses of palonosetron for prevention of postoperative nausea and vomiting in day care laparoscopic gynaecological surgery: A dose ranging, randomised controlled trial.

作者信息

Jain Divya, Jain Kajal, Bala Indu, Gandhi Komal

机构信息

From the Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India (DJ, KJ, IB, KG).

出版信息

Eur J Anaesthesiol. 2016 Feb;33(2):104-9. doi: 10.1097/EJA.0000000000000391.

DOI:10.1097/EJA.0000000000000391

PMID:26673802

Abstract

BACKGROUND

Palonosetron 75 mcg is being used for the prevention of postoperative nausea and vomiting. However, weight-adjusted doses in laparoscopic surgery are unevaluated.

AIM

To determine the response to three doses of palonosetron (0.5, 1.0, or 1.5 mcg kg⁻¹) over 72 h in the postoperative period in women undergoing laparoscopic gynaecological procedures.

DESIGN

A randomised dose-response study.

SETTING

A tertiary care hospital and research institute in north India from July to December 2014.

PATIENTS

American society of Anesthesiologists physical status I and II women, from 18 to 60 years old, undergoing laparoscopic gynaecological procedures on a day care basis.

METHODS

Patients were randomised to receive palonosetron 0.5, 1 and 1.5 mcg kg⁻¹ intravenously before induction of anaesthesia.

MAIN OUTCOMES MEASURES

The primary outcome was the proportion of patients with a complete response (i.e. who neither vomited nor required additional antiemetic drugs for nausea during the first 72 postoperative hours). The proportion of patients having nausea or emetic episodes and the requirement for rescue antiemetics and analgesics during the 72-h period were recorded as secondary outcomes.

RESULTS

With palonosetron, there was a significant dose-dependent increase (37.5 vs. 67.5 vs. 75%, P < 0.001) in proportion of patients with a complete response during the 72 h. This was associated with a significant dose-dependent decrease in the proportion of patients with nausea (77.5 vs. 47.5 vs. 35%, P < 0.001) and vomiting (47.5 vs. 32.5 vs. 12.5%, P = 0.003).

CONCLUSION

Following laparoscopic gynaecological surgery, intravenous palonosetron has a dose-dependent prophylactic effect against postoperative nausea and vomiting during the first 72 postoperative hours.

TRIAL REGISTRATION

The trial was registered with Clinical trial registry of India(CTRI/2014/09/004987).

摘要

背景

帕洛诺司琼75微克正用于预防术后恶心和呕吐。然而，腹腔镜手术中根据体重调整的剂量尚未得到评估。

目的

确定接受腹腔镜妇科手术的女性在术后72小时内对三种剂量的帕洛诺司琼（0.5、1.0或1.5微克/千克）的反应。

设计

一项随机剂量反应研究。

地点

2014年7月至12月在印度北部的一家三级护理医院和研究机构。

患者

美国麻醉医师协会身体状况I级和II级、年龄在18至60岁之间、在日间护理基础上接受腹腔镜妇科手术的女性。

方法

患者在麻醉诱导前随机接受静脉注射0.5、1和1.5微克/千克的帕洛诺司琼。

主要观察指标

主要结局是完全缓解的患者比例（即在术后首72小时内既未呕吐也未因恶心需要额外使用止吐药物的患者）。恶心或呕吐发作的患者比例以及在72小时期间对急救止吐药和镇痛药的需求作为次要结局进行记录。

结果

使用帕洛诺司琼后，72小时内完全缓解的患者比例有显著的剂量依赖性增加（37.5%对67.5%对75%，P<0.001）。这与恶心患者比例的显著剂量依赖性降低（77.5%对47.5%对35%，P<0.001）和呕吐患者比例的显著剂量依赖性降低（47.5%对32.5%对12.5%，P = 0.003）相关。