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Completed

NCT Number: NCT01819857

Droperidol and Cardiac Repolarization

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?

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Key information

Conditions

Cardiac Repolarization

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Gdansk

Gdansk, 80-214, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xomolix 0.625 mg intravenously

Drug

intravenous administration of 0.625 mg droperidol

Xomolix 1.25 mg

Drug

intravenous administration of 1.25 mg droperidol

Zofran 8 mg

Drug

intravenous administration of 8 mg ondansetron

Primary outcomes

  1. Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value

    Time frame: 20 minutes

Secondary outcomes

  1. Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms

    Time frame: 20 min

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2013
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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