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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arrhythmia, Respiratory Arrest

Intervention / Treatment
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* Drug: Atropine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: Atropine<br>Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation. | Drug: Atropine<br>* Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.<br>|
| Placebo Comparator: 2: Placebo<br>1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation. | Drug: Placebo<br>* 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of dysrhythmias |  | during percutaneous ethanol instillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical complications |  | during percutaneous ethanol instillation and consecutive 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atropine, percutaneous ethanol instillation, hepatoma, bradycardia, arrhythmia