drugset / Trial / NCT01819857

Droperidol and Cardiac Repolarization

NCT01819857

Phase 4 Completed 75 enrolled Medical University of Gdansk
RandomizedParallel-groupDouble-blindPrevention

Summary

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?

Timeline

Start
2011-06
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Droperidol Small molecule 0.625 mg Intravenous
Comparator Droperidol Small molecule 1.25 mg Intravenous
Comparator Ondansetron Other / unclassified 8 mg Intravenous