Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- postoperative nausea and vomiting
研究概览
简要总结
Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia 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
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ
- •patient scheduled for elective gynecological laparoscopic surgery.
排除标准
- •hepatorenal disease
- •BMI > 35 kg/m2
- •allergy to ramosetron
- •gastrointestinal disease
- •vomiting within 24h
- •administration of antiemetics or opioids within 24h
- •QT prolongation (QTc > 440ms)
- •problem with communication
研究组 & 干预措施
ramosetron 0.3
干预措施: ramosetron 0.3 (Drug)
ramosetron 0.45
干预措施: ramosetron 0.45 (Drug)
ramosetron 0.6
干预措施: ramosetron 0.6 (Drug)
结局指标
主要结局
postoperative nausea and vomiting
时间窗: within 48h after surgery
incidence of nausea and vomiting during the first 48 h after surgery
次要结局
未报告次要终点