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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-01-31

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.

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Detailed Description

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Conditions

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Arrhythmia Respiratory Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1: Atropine

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

Group Type ACTIVE_COMPARATOR

Atropine

Intervention Type DRUG

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

2: Placebo

1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Interventions

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Atropine

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

Intervention Type DRUG

Placebo

1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No