Comparison of Ramosetron Pre-treatment Time for Postoperative Nausea and Vomiting (PONV) and QTc Prolongation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- QTc interval change
研究概览
简要总结
Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.
详细描述
This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-, and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival to PACU, and 24-h after discharge from PACU.
Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size difference of 0.9.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients who underwent laparoscopic gynecologic surgery
排除标准
- •preoperative bradyarrhythmia in ECG
研究组 & 干预措施
ramosetron iv at induction (I)
0.6mg of ramosetron is given to the patients intravenously at anesthesia induction
干预措施: Ramosetron (Drug)
ramosetron iv at recovery (R)
0.6mg of ramosetron is given to the patients intravenously at end of surgery
干预措施: Ramosetron (Drug)
结局指标
主要结局
QTc interval change
时间窗: within 10 min after arrival at PACU, and 24 hour after discharge from PACU
Difference of QTc interval from preoperative value
次要结局
未报告次要终点
研究者
Ka Young Rhee
Associate Professor
Konkuk University Medical Center