Clinical trial NCT00575523: Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Official title: Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia
Respiratory Arrest
Keywords: atropine
percutaneous ethanol instillation
hepatoma
bradycardia
arrhythmia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Occurrence of dysrhythmias
timeFrame: during percutaneous ethanol instillation
Secondary outcomes:
measure: Clinical complications
timeFrame: during percutaneous ethanol instillation and consecutive 24 hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Div. of Gastroenterology and Hepatology, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Arnulf Ferlitsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1365-2362.2004.01321.x.
citation: Arnulf F, Monika S, Herwig S, Monika H, Johannes PD, Gregor U, Alfred G, Markus PR. Atropine for prevention of cardiac dysrhythmias in patients with hepatocellular carcinoma undergoing percutaneous ethanol instillation: a randomized, placebo-controlled, double-blind trial. Liver Int. 2009 May;29(5):715-20. doi: 10.1111/j.1478-3231.2008.01905.x. Epub 2008 Oct 27.