NCT01819857

Droperidol and Cardiac Repolarization

The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Cardiac Repolarization

Interventions

Type	Name	Description
DRUG	Xomolix 0.625 mg intravenously	intravenous administration of 0.625 mg droperidol
DRUG	Xomolix 1.25 mg	intravenous administration of 1.25 mg droperidol
DRUG	Zofran 8 mg	intravenous administration of 8 mg ondansetron

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-03-28
• Last updated: 2013-08-07

Locations

1 site across 1 country: Poland