The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value
研究概览
简要总结
For many years droperidol has been used in prophylaxis and therapy of PONV. Information that it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those data didn't base on solid examinations confirming torsadogenic action of droperidol. It is known that droperidol prolongs time of repolarisation, but there wasn't any data confirming its impact on transmural dispersion of repolarisation. Only estimation both of those actions in one time allows to define for sure arrhythmogenic role of droperidol.
The aim of this study was to answer the questions:
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Does droperidol make an significant prolongation of heart repolarisation, expressed as corrected QT interval?
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Does droperidol cause increase of transmural dispersion of repolarisation?
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Does possible torsadogenic acting of droperidol depend on dose of drug?
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Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?
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What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?
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
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age 18-60 years
- •sex: males
- •ASA score I or II
排除标准
- •treatment with drugs influencing cardiac repolarization
- •coronary artery disease
- •heart insufficiency NYHA>1
- •serum electrolyte disturbances
- •hypersensitivity to droperidol and/or ondansetron
研究组 & 干预措施
Droperidol 0.625 mg intravenously
干预措施: Xomolix 0.625 mg intravenously (Drug)
Droperidol 1.25 mg intravenously
干预措施: Xomolix 1.25 mg (Drug)
Ondansetron 8 mg intravenously
干预措施: Zofran 8 mg (Drug)
结局指标
主要结局
Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value
时间窗: 20 minutes
次要结局
- Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms(20 min)
研究者
Radoslaw Owczuk
Principle Investigator
Medical University of Gdansk