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

Arrhythmia Clinical Trial

— atropinePEI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575523
• Other study ID #: atropinePEI
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2007
• Last updated: January 23, 2008
• Start date: October 2003
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Arrhythmia
• Respiratory Arrest

Intervention

Drug:
• Atropine
Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.
• Placebo
1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Locations

Country	Name	City	State
Austria	Div. of Gastroenterology and Hepatology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of dysrhythmias		during percutaneous ethanol instillation	Yes
Secondary	Clinical complications		during percutaneous ethanol instillation and consecutive 24 hours	Yes