Arrhythmia, Respiratory Arrest
Conditions
Keywords
atropine, percutaneous ethanol instillation, hepatoma, bradycardia, arrhythmia
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.
Interventions
DRUGAtropine
Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.
DRUGPlacebo
1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dysrhythmias | during percutaneous ethanol instillation |
Secondary
| Measure | Time frame |
|---|---|
| Clinical complications | during percutaneous ethanol instillation and consecutive 24 hours |
Countries
Austria
Outcome results
None listed