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Trial record 8 of 28 for:    INAPSINE OR MCN-JR-4749 OR DROPERIDOL OR DROLEPTAN OR Dridol OR R-4749

Droperidol and Cardiac Repolarization

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ClinicalTrials.gov Identifier: NCT01819857
Recruitment Status : Completed
First Posted : March 28, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Radoslaw Owczuk, Medical University of Gdansk

Brief 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?

Condition or disease Intervention/treatment Phase
Cardiac Repolarization Drug: Xomolix 0.625 mg intravenously Drug: Xomolix 1.25 mg Drug: Zofran 8 mg Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.
Study Start Date : June 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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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




Primary Outcome Measures :
  1. Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms [ Time Frame: 20 min ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819857


Locations
Poland
Medical University of Gdansk
Gdansk, Poland, 80-214
Sponsors and Collaborators
Medical University of Gdansk

Responsible Party: Radoslaw Owczuk, Principle Investigator, Medical University of Gdansk
ClinicalTrials.gov Identifier: NCT01819857     History of Changes
Other Study ID Numbers: RO4
MUG4 ( Other Identifier: Medical University of Gdansk )
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Droperidol
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Adjuvants, Anesthesia
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents