Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Laparoscopy for benign gynecologic disease
排除标准
- •Vomiting within 24 hours before surgery
- •Not using patient controlled analgesics postoperatively
研究组 & 干预措施
Control
Single dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, placebo will be intravenously injected at 4 hours after surgery.
干预措施: Ramosetron (Drug)
Experimental
Double dose of antiemetics. Specifically, Ramosetron 0.3 mg will be intravenously injected when surgery is ended. Additionally, Ramosetron 0.3 mg will be intravenously injected at 4 hours after surgery.
干预措施: Ramosetron (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: Postoperative 24 hours
The percentage of patients who experienced neither nausea nor vomiting within 24 hours after surgery
次要结局
未报告次要终点
研究者
Kidong Kim
Professor
Seoul National University Hospital