NCT01476280已完成不适用
A Randomized Double Blind Study to Evaluate Efficacy of Ramosetron and Palonosetron for Prevention of Postoperative Nausea and Vomiting After Gynaecological Laparoscopic Surgery
Incheon St.Mary's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年5月最近更新:
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
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting for 48 hours after surgery
研究概览
简要总结
Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor antagonists and this randomized double blind study was designed to compare efficacy of ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator hypothesized that palonosetron would have stronger and longer lasting antiemetic effect compared with ramosetron and evaluated the patients for the first 48 hours after 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status 1 or 2
- •Elective gynaecological laparoscopic surgery of ≥ 1h duration
排除标准
- •Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
- •Vomiting or retching in the 24 h preceding surgery
- •Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
- •Ongoing vomiting from gastrointestinal disease
研究组 & 干预措施
Palonosetron
Sham Comparator
干预措施: palonosetron (Drug)
Ramosetron
Sham Comparator
干预措施: Ramosetron (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting for 48 hours after surgery
时间窗: for 48 hours after surgery
次要结局
- severity of nausea for 48 hours after surgery(for 48 hours after surgery)
研究者
Soo Kyoung Park
Clinical professor
Incheon St.Mary's Hospital
研究点 (1)
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