A placebo-controlled clinical trial to evaluate the efficacy and safety of domestic palonosetron hydrochloride injection on the prevention of postoperative nausea and vomiting
- VernacularTitle:以安慰剂为对照评价国产盐酸帕洛诺司琼注射液预防术后恶心呕吐的有效性和安全性
- Author:
Nan XU
;
Weixiu YUAN
;
Ming TIAN
;
Buwei YU
;
Yuanchang XIONG
;
Jin ZHOU
;
Hong MA
;
Weimin CHEN
;
Jun LUO
;
Zhixun LAN
;
Hailong DONG
;
Rongliang XUE
;
Xiongqing HUANG
;
Nuoer SANG
;
Yuguang HUANG
- Publication Type:Journal Article
- Keywords:
Domestic palonosetron hydrochloride;
Efficacy;
Safety;
Postoperative nausea and vomitting
- From:
The Journal of Clinical Anesthesiology
2014;(7):651-655
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of domestic palonosetron hydrochlo-ride injection on its prevention of postoperative nausea and vomiting.Methods A multi-centered,ran-domized,double-blinded and placebo-controlled clinical trial was carried out.A total of 281 patients were enrolled,with 141 of patients in study group and 140 of patients in control group respectively. 0.075 mg of intravenous palonosetron hydrochloride injection was delivered in the study group before anesthesia induction.The drug was substituted by 1.5 ml of NS in the control group.All anesthesia inductions were conducted by the intravenous injection of propofol,fentanyl and rocuronium,and were maintained with sevoflurane and fentanyl.Complete remission rate and treatment failure cut-off time of vomiting were evaluated at 0-6 h,6-72 h,0-72 h postoperatively.Results In the study group CR% 0-6 h,6-72 h and 0-72 h were 107 (75.89%),104 (73.76%)and 92 (65.25%),the control group was 81 (57.86%),70 (50%)and 62 (42.86%),CR% of the study group was significantly higher than that of the control group (P <0.01).Insignificant statistical difference but significant clin-ical difference exists in their treatment failure cut-off time,386.5 min and 300.0 min,respectively be-tween the groups.Conclusion Domestic palonosetron hydrochloride injection is safe and effective in the prevention of postoperative nausea and vomiting.
