Comparison of the Effect of Ondansetron and Combined Ondansetron and Betahistine on Postoperative Nausea and Vomiting After Gynecological Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- postoperative nausea and vomiting
研究概览
简要总结
Many patients undergoing gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists such as ondansetron. Involvement of multiple types of receptors and factors may be a reason for inadequate control of PONV with a single agent. Betahistine, a histamine antagonist at H1 receptor and antagonist at H3 receptor, is widely used as a treatment of dizziness. Dizziness is one of the cause of nausea and vomiting. This study is to compare the effects of ondansetron and combined ondansetron and betahistine in preventing PONV in high-risk patients receiving intravenous opioid-based patient-controlled analgesia (IV-PCA) after gynecological laparoscopic 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient scheduled for elective gynecological laparoscopic surgery
- •American society of Anesthesiologists physical class I, Ⅱ, between the ages of 20 and 70 years
排除标准
- •hepatorenal disease
- •BMI > 35 kg/m2
- •allergy to ondansetron or betahistine
- •gastrointestinal disease
- •vomiting within 24h
- •administration of antiemetics or opioids within 24h
- •QT prolongation (QTc > 440ms)
- •Pheochromocytoma
- •problem with communication
研究组 & 干预措施
ondansetron-betahistine
ondansetron-betahistine group
干预措施: ondansetron-betahistine (Drug)
ondansetron
ondansetron group
干预措施: ondansetron (Drug)
结局指标
主要结局
postoperative nausea and vomiting
时间窗: at postoperative 24h
evaluation of nausea and vomiting with verbal rating scale (VRS, 0, no nausea; 10, worst imaginable nausea)
次要结局
未报告次要终点