Droperidol and Cardiac Repolarization

August 5, 2013 updated by: Radoslaw Owczuk, Medical University of Gdansk

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland, 80-214
        • Medical University of Gdansk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 9, 2013

First Submitted That Met QC Criteria

March 25, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RO4
  • MUG4 (Other Identifier: Medical University of Gdansk)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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