Droperidol and Cardiac Repolarization

Cardiac Repolarization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819857
• Other study ID #: RO4
• Secondary ID: MUG4
• Status: Completed
• Phase: Phase 4
• First received: March 9, 2013
• Last updated: August 5, 2013
• Start date: June 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Medical University of Gdansk
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Repolarization

Intervention

Drug:
• Xomolix 0.625 mg intravenously
intravenous administration of 0.625 mg droperidol
• Xomolix 1.25 mg
intravenous administration of 1.25 mg droperidol
• Zofran 8 mg
intravenous administration of 8 mg ondansetron

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value		20 minutes	Yes
Secondary	Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms		20 min	Yes