Droperidol and Cardiac Repolarization

Study Overview
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Brief Summary
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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?

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

Conditions
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Cardiac Repolarization

Intervention / Treatment
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* Drug: Xomolix 0.625 mg intravenously
* Drug: Xomolix 1.25 mg
* Drug: Zofran 8 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-60 years sex: males ASA score I or II Exclusion Criteria: treatment with drugs influencing cardiac repolarization coronary artery disease heart insufficiency NYHA>1 serum electrolyte disturbances hypersensitivity to droperidol and/or ondansetron

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Droperidol 0.625 mg intravenously<br> | Drug: Xomolix 0.625 mg intravenously<br>* intravenous administration of 0.625 mg droperidol<br>|
| Active Comparator: Droperidol 1.25 mg intravenously<br> | Drug: Xomolix 1.25 mg<br>* intravenous administration of 1.25 mg droperidol<br>|
| Active Comparator: Ondansetron 8 mg intravenously<br> | Drug: Zofran 8 mg<br>* intravenous administration of 8 mg ondansetron<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value |  | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms |  | 20 min |