Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
- Registration Number
- NCT00575523
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1: Atropine Atropine Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation. 2: Placebo Placebo 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
- Primary Outcome Measures
Name Time Method Occurrence of dysrhythmias during percutaneous ethanol instillation
- Secondary Outcome Measures
Name Time Method Clinical complications during percutaneous ethanol instillation and consecutive 24 hours
Trial Locations
- Locations (1)
Div. of Gastroenterology and Hepatology, Medical University of Vienna
🇦🇹Vienna, Austria