Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Occurrence of dysrhythmias
研究概览
简要总结
Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied by clinical complications such as unconsciousness, respiratory arrest or seizure like symptoms. Study purpose is to evaluate whether the use of i.v. Atropine before starting ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized, placebo controlled, double blinded study. Atropine or saline solution will be administered intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A 6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal possibly occurring dysrhythmias.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation
排除标准
- •contraindication for the administration of atropine like
- •narrow angle glaucoma
- •mechanic stenoses of the GI-tract
- •clinically relevant prostatic hypertrophy
- •paralytic ileus
- •myasthenia gravis
- •severe cerebral sclerosis
- •acute lung edema
- •acute myocardial infarction
- •cardiac insufficiency
- •hyperthyroidism
- •patients with contraindication to undergo percutaneous ethanol instillation
研究组 & 干预措施
1: Atropine
Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation.
干预措施: Atropine (Drug)
2: Placebo
1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of dysrhythmias
时间窗: during percutaneous ethanol instillation
次要结局
- Clinical complications(during percutaneous ethanol instillation and consecutive 24 hours)
