Droperidol and Cardiac Repolarization

Medical University of Gdansk

Status and phase: Completed; Phase 4

Conditions: Cardiac Repolarization

Treatments: Drug: Xomolix 0.625 mg intravenously; Drug: Xomolix 1.25 mg; Drug: Zofran 8 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01819857

MUG4 (Other Identifier)

RO4

Details and patient eligibility

About

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?

7. Does droperidol cause increase of transmural dispersion of repolarisation?

8. Does possible torsadogenic acting of droperidol depend on dose of drug?

9. Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?

10. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?

Enrollment: 75 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Droperidol 0.625 mg intravenously

Active Comparator group

Treatment:

Drug: Xomolix 0.625 mg intravenously

Droperidol 1.25 mg intravenously

Active Comparator group

Treatment:

Drug: Xomolix 1.25 mg

Ondansetron 8 mg intravenously

Active Comparator group

Treatment:

Drug: Zofran 8 mg