Droperidol and Cardiac Repolarization
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|ClinicalTrials.gov Identifier: NCT01819857|
Recruitment Status : Completed
First Posted : March 28, 2013
Last Update Posted : August 7, 2013
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?
- Does droperidol cause increase of transmural dispersion of repolarisation?
- Does possible torsadogenic acting of droperidol depend on dose of drug?
- Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?
- What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Repolarization||Drug: Xomolix 0.625 mg intravenously Drug: Xomolix 1.25 mg Drug: Zofran 8 mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
|Active Comparator: Droperidol 0.625 mg intravenously||
Drug: Xomolix 0.625 mg intravenously
intravenous administration of 0.625 mg droperidol
|Active Comparator: Droperidol 1.25 mg intravenously||
Drug: Xomolix 1.25 mg
intravenous administration of 1.25 mg droperidol
|Active Comparator: Ondansetron 8 mg intravenously||
Drug: Zofran 8 mg
intravenous administration of 8 mg ondansetron
- Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value [ Time Frame: 20 minutes ]
- Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms [ Time Frame: 20 min ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819857
|Medical University of Gdansk|
|Gdansk, Poland, 80-214|