NCT02139241已完成不适用
The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- corrected QT interval (QTc interval)
研究概览
简要总结
The purpose of this study is to assess the effects of ramosetron on corrected QT interval in patients undergoing off pump coronary artery bypass 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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective off-pump coronary artery bypass graft surgery
排除标准
- •Emergency operation
- •preoperative use of any inotropics or mechanical assist device
- •severe liver disease (>Child class II)
- •dialysis dependent renal failure
- •Left ventricular ejection fraction <30 %
- •Combined major surgery like carotid endarterectomy
- •Previous allergy history to any 5-hydroxytryptamine type 3 (5-HT3) antagonist
- •Preoperative QT prolongation ( 500 >msec) or arrhythmia
研究组 & 干预措施
Ramosetron
Experimental
Intravenous administration of ramosetron 0.3 mg before the induction of general anesthesia
干预措施: Ramosetron (Drug)
Control
Placebo Comparator
Intravenous administration of 2ml normal saline before the induction of general anesthesia
干预措施: Normal saline (Drug)
结局指标
主要结局
corrected QT interval (QTc interval)
时间窗: up to 240 minutes after induction of general anesthesia
at 1,2,3,5,10,15,30,45,60,90,120,240 minutes after ramosetron injection, at the time of operation end, ICU 12hour
次要结局
- hypotension or bradycardia during the peri-induction period and the coronary anastomosis period(up to 240 minutes after induction of general anesthesia)
- incidence of postoperative atrial fibrillation(during the hospital stay (from ICU admission to hospital discharge, average of 1 week))
研究者
研究点 (1)
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