Completed

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

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What is being tested

Xomolix 0.625 mg intravenously

+ Xomolix 1.25 mg

+ Zofran 8 mg

Drug
Who is being recruted

From 18 to 60 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: June 2011
See protocol details

Summary

Principal SponsorMedical University of Gdansk
Last updated: August 7, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2011

Actual date on which the first participant was enrolled.

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?

NCT01819857
Principal SponsorMedical University of Gdansk
Last updated: August 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
ASA score I or II
age 18-60 years
sex: males
5 exclusion criteria prevent from participating
coronary artery disease
heart insufficiency NYHA > 1
hypersensitivity to droperidol and/or ondansetron
serum electrolyte disturbances
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Group III

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical University of Gdansk

Gdansk, PolandOpen Medical University of Gdansk in Google Maps
CompletedOne Study Center