Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Incidence of PONV in ambulatory gynecologic laparoscopy
研究概览
简要总结
The purpose of this study is to compare the incidence of Postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory gynecologic laparoscopy
- •Age 18-45 years
- •ASA class 1-2
排除标准
- •The patients who take opioid, steroid, pyschotics or antiemetic drug within 24 hours before surgery
- •History of antiemetic, anesthetic and analgesic drugs allergy
- •Pregnancy or breast feeding
- •Body mass index >34 kg/square metre
研究组 & 干预措施
Multimodal antiemetic management group
Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg
干预措施: Dexamethasone (Drug)
Multimodal antiemetic management group
Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg
干预措施: Ondansetron (Drug)
Multimodal antiemetic management group
Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg
干预措施: Dimenhydrinate (Drug)
Control group
Control group: Low and moderate risk : no PONV prophylaxis High risk : Ondansetron 4 mg. iv Extremely high risk : Ondansetron 4 mg .iv
干预措施: Ondansetron (Drug)
结局指标
主要结局
Incidence of PONV in ambulatory gynecologic laparoscopy
时间窗: four year
次要结局
未报告次要终点
研究者
Thanyamon Asampinwat
Assistant Professor
Prince of Songkla University