MedTrace Logo

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

NCT00575523 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2008-01-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Arnulf Ferlitsch, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Completion
2008-01-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00575523 on ClinicalTrials.gov