Gender Influence on Torsadogenic Actions of Droperidol Used as Postoperative Nausea and Vomiting Prophylaxis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time interval between T wave peak and T wave end
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is a quite common complication affecting patients undergoing general anesthesia. There are a few pharmacological agents of well known effectiveness in reducing the risk of PONV. One of them is droperidol, which is a butyrophenone derivant. It has been widely used for the prevention and treatment of PONV due to its high effectiveness and low cost. Though, droperidol has a relevant side effect, that is a repolarization prolongation. This can lead to life-threatening cardiac arrhythmias: polymorphic ventricular tachycardia (torsades de pointes, TdP) that can degenerate into ventricular fibrillation and cardiac arrest. This was a reason why in 2001 the FDA issued a "black box" warning on droperidol. Ever since papers focused on this problem have described the influence of small doses of droperidol on TdP genesis as weak. This could be explained by the fact, that QT/QTc (corrected QT) interval prolongation, which represents prolonged cardiac repolarization on ECG, is not the sole determinant of a drug's potential to cause arrhythmia. Another electrocardiographical marker of torsadogenic action is increased transmural dispersion of repolarization (TDR). TDR represents differences in the repolarization between myocardial "layers" (like epicardium, endocardium, myocardium cells). It is believed that the induction of QT/QTc lengthening must coexist with TDR increase at the same time to promote torsadogenic changes.
It has been known, on the basis of research, that females have been more potent to torsadogenic actions of pharmacological agents than males. That could be related to estrogen influence on ECG parameters, which had been proven on animal model. It hasn't been investigated, whether gender is an important factor when considering droperidol's torsadogenic potential.
The aim of this study is to answer a hypothesis, that women are more potent to torsadogenic actions of droperidol in comparison with men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 45 years old
- •ASA (American Society of Anaesthesiologists) physical status 1 and 2
排除标准
- •lack of informed consent
- •ASA (American Society of Anaesthesiologists) physical status 3 and more
- •admittance of repolarisation affecting drugs like: antiarrhythmics (Williams group I-IV), psychotropics, macrolides, antireflux drugs
- •ischaemic heart disease
- •cardiac failure NYHA (Hew York Heart Association) 1 and more
- •congenital or acquired heart defects
- •arrhythmias in anamnesis
- •hormonal contraception,
- •postmenopausal
- •neoplasms
研究组 & 干预措施
Droperidol group
Droperidol (Xomolix, Kyowa Kirin) 1.25 mg i.v. bolus
干预措施: Droperidol Injectable Solution (Drug)
结局指标
主要结局
Time interval between T wave peak and T wave end
时间窗: Change from baseline T peak - T end time at 5,10,15 and 20 minutes after administration of 1.25 mg droperidol.
measured in milliseconds
QT and corrected QT interval time
时间窗: Change from baseline QT and corrected QT interval time at 5,10,15 and 20 minutes after administration of 1.25 mg droperidol
measured in milliseconds
次要结局
未报告次要终点
研究者
Radosław Owczuk
Clinical Professor, Head of Department of Anaesthesiology and Intensive Care
Medical University of Gdansk