Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arrhythmia; Respiratory Arrest
Intervention: Atropine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Arnulf Ferlitsch, MD, Principal Investigator, Affiliation: Medical University of Vienna
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.
Clinical Details
Official title: Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Occurrence of dysrhythmias
Secondary outcome: Clinical complications
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Div. of Gastroenterology and Hepatology, Medical University of Vienna, Vienna 1090, Austria
Additional Information
Related publications: Ferlitsch A, Kreil A, Bauer E, Schmidinger H, Schillinger M, Gangl A, Peck-Radosavljevic M. Bradycardia and sinus arrest during percutaneous ethanol injection therapy for hepatocellular carcinoma. Eur J Clin Invest. 2004 Mar;34(3):218-23.
Starting date: October 2003
Ending date: January 2008
Last updated: January 23, 2008
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