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临床试验/NCT00575523
NCT00575523已完成4 期

Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation.

干预措施: Atropine (Drug)

2: Placebo

Placebo Comparator

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)

研究者

申办方类型
Other

研究点 (1)

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