NCT00575523

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmia
• Respiratory Arrest

Interventions

Type	Name	Description
DRUG	Atropine	Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.
DRUG	Placebo	1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Timeline

• Start date: 2003-10-01
• Completion: 2008-01-01
• First posted: 2007-12-18
• Last updated: 2008-01-25

Locations

1 site across 1 country: Austria