临床试验/NCT01013012

NCT01013012已完成4 期

Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery

Yonsei University0 个研究点目标入组 94 人开始时间: 2008年1月最近更新: 2012年2月3日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Yonsei University
入组人数: 94
主要终点: the incidence of postoperative nausea and vomiting(PONV)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Ages 18 to 65 years old

排除标准

•Patients who is taking steroid or who had been treated for the gastrointestinal disease
•Patients who have troubles with the kidney or liver
•Patients transferring to the ICU after the surgery
•overfat patients
•Patients who had taken antiemetics within 24 hours before the surgery

研究组 & 干预措施

Group A

Active Comparator

Group A : saline 1 ml + ramosetron 6μg/kg

干预措施: ramosetron with saline (Drug)

Group B

Experimental

Group B : dexamethasone 4 mg + ramosetron 6μg/kg

干预措施: ramosetron with dexamethasone (Drug)

结局指标

主要结局

the incidence of postoperative nausea and vomiting(PONV)

时间窗: After spinal surgery

incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients

次要结局

未报告次要终点

研究者

发起方

Yonsei University

申办方类型

Other

责任方

Sponsor

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