Cardiac Repolarization Clinical Trial
Official title:
The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.
For many years droperidol has been used in prophylaxis and therapy of PONV. Information that
it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those
data didn't base on solid examinations confirming torsadogenic action of droperidol. It is
known that droperidol prolongs time of repolarisation, but there wasn't any data confirming
its impact on transmural dispersion of repolarisation. Only estimation both of those actions
in one time allows to define for sure arrhythmogenic role of droperidol.
The aim of this study was to answer the questions:
6. Does droperidol make an significant prolongation of heart repolarisation, expressed as
corrected QT interval?
1. Does droperidol cause increase of transmural dispersion of repolarisation?
2. Does possible torsadogenic acting of droperidol depend on dose of drug?
3. Does ondansetron cause changes of electrical heart function, suggesting its
possibilities to induce TdP tachycardia?
4. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV
in people not suffering from cardiovascular diseases?
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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