Droperidol and Cardiac Repolarization

Phase 4

Completed

• Conditions: Cardiac Repolarization
• Interventions: Drug: Xomolix 0.625 mg intravenously; Drug: Xomolix 1.25 mg; Drug: Zofran 8 mg

• Registration Number: NCT01819857
• Lead Sponsor: Medical University of Gdansk

Brief 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2013-03-09
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Droperidol 0.625 mg intravenously	Xomolix 0.625 mg intravenously	-
Droperidol 1.25 mg intravenously	Xomolix 1.25 mg	-
Ondansetron 8 mg intravenously	Zofran 8 mg	-

Primary Outcome Measures

Name	Time	Method
Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value	20 minutes

Secondary Outcome Measures

Name	Time	Method
Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms	20 min

Trial Locations

Locations (1)

Medical University of Gdansk; 🇵🇱 Gdansk, Poland