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临床试验/CTRI/2018/01/011293
CTRI/2018/01/011293已完成不适用

A comparative study of intravenous ondensetron and palonosetron as pretreatment to prevent pain on injection of propofol

Shamshuzoha M1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年1月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Pain during injection of Propofol

研究概览

简要总结

Intravenous Propofol causes pain on injection, different drugs have been used to prevent Propofol injection pain 5HT3 receptor antagonist which are commonly used for prevention of nausea and vomiting are also used for having analgesic property. Different 5HT3 receptor antagonists were used as pretreatment in preventing this pain. In literature there are very minimal studies comparing Ondensetron and Palonosetron as pretreatment in preventing the Propofol injection pain.

The overall incidence of pain in group Ondensetron and group Palonosetron was 32% and 26% respectively. 4% of patient in group Ondensetron and 2% of patient in group Palonosetron complained of severe pain. Incidence of post operative nausea and vomiting in group Palonosetron (20%) was comparatively lower than group Ondensetron (38%).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Posted for elective Laproscopic surgery under General anesthesia.

排除标准

  • Patients with presence of infection on the dorsum of non-dominant hand Patients with thin dorsal veins Patients with known hypersensitivity to Propofol, Ondensetron and Palonosetron.

结局指标

主要结局

Pain during injection of Propofol

时间窗: 1, 3 and 5 minute after induction

次要结局

  • Post operative nausea and vomiting(Noted for 24 hours Post operative period)

研究者

发起方
Shamshuzoha M
申办方类型
Other [self]

研究点 (1)

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