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

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Arrhythmia; Respiratory Arrest

Treatments: Drug: Atropine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00575523

atropinePEI

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

1: Atropine

Active Comparator group

Description:

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

Treatment:

Drug: Atropine

2: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo