NCT01650961已完成不适用
The Effect of Palonosetron on the QTc Interval During Perioperative Period
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
- 100
- 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 palonosetron on corrected QT interval duration during and after general anesthesia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective abdominal surgery under general anesthesia
排除标准
- •Cardiac valvular disease
- •Clinically significant arrhythmias including atrial fibrillation
- •Anti-emetics within 24 hours before surgery
- •Steroids within 1 week before surgery
- •Cancer chemotherapy or radiotherapy within 4 weeks before surgery
- •Diabetes mellitus
- •Pregnancy
- •Patients receives a QT-prolonging drug
研究组 & 干预措施
Palonosetron
Experimental
Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia
干预措施: Palonosetron (Drug)
Control
Placebo Comparator
Intravenous administration of 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 90 minutes after induction of general anesthesia
at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation
次要结局
- proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female(up to 2 hours after induction of general anesthesia)
- corrected QT interval (QTc interval) at Postanesthetic care unit(up to 1 hour after arrival on postanesthetic care unit)
- Incidence of postoperative nausea and vomiting(for 24 hours after surgery)
- proportion of patients who have more than 500 ms of corrected QT interval (QTc interval)(up to 2 hours after induction of general anesthesia)
研究者
研究点 (1)
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