NCT02744508已完成不适用
Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- incidence of clinically significant PONV with PONV impact scale
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV preventive effect of palonosetron and combination of palonosetron and dexamethasone.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are undergoing minor orthopedic surgery.
- •IV patient controlled analgesia
排除标准
- •minority (0~19 year)
- •patients who are belongs to ASA class 3 or more, and have underlying complicated cardiovascular or psychological disease.
- •Steroid medication
- •Diabetes Mellitus medication
研究组 & 干预措施
P group
Active Comparator
Palonosetron group
干预措施: palonosetron (Drug)
PD group
Experimental
Palonosetron and dexamethasone group
干预措施: palonosetron with dexamethasone (Drug)
结局指标
主要结局
incidence of clinically significant PONV with PONV impact scale
时间窗: 72 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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