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Droperidol and Cardiac Repolarization

NCT01819857 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2013-08-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01819857 on ClinicalTrials.gov