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Completed

NCT Number: NCT00575523

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

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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Key information

Conditions

Arrhythmia Adenocarcinoma Apnea Arrhythmias, Cardiac Bradycardia Carcinoma Carcinoma, Hepatocellular Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Heart Diseases Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Arrest Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Div. of Gastroenterology and Hepatology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Occurrence of dysrhythmias

    Time frame: during percutaneous ethanol instillation

Secondary outcomes

  1. Clinical complications

    Time frame: during percutaneous ethanol instillation and consecutive 24 hours

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: atropinePEI

Important dates

Study start
2003
Study completion
2008
First posted
Dec 18, 2007
Registry last updated
Jan 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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