Droperidol and Cardiac Repolarization

NCT01819857 | Completed Phase 4

• 2 other identifiers: RO4MUG4
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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. 1.Does droperidol cause increase of transmural dispersion of repolarisation?
2. 2.Does possible torsadogenic acting of droperidol depend on dose of drug?
3. 3.Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?
4. 4.What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?

Conditions

Cardiac Repolarization

Outcome Measures

Primary Outcomes (1)

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

  20 minutes

Secondary Outcomes (1)

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

  20 min

Study Arms (3)

Droperidol 0.625 mg intravenously

ACTIVE COMPARATOR

Drug: Xomolix 0.625 mg intravenously

Droperidol 1.25 mg intravenously

ACTIVE COMPARATOR

Drug: Xomolix 1.25 mg

Ondansetron 8 mg intravenously

ACTIVE COMPARATOR

Drug: Zofran 8 mg

Interventions

Xomolix 0.625 mg intravenously DRUG

intravenous administration of 0.625 mg droperidol

Droperidol 0.625 mg intravenously

Xomolix 1.25 mg DRUG

intravenous administration of 1.25 mg droperidol

Droperidol 1.25 mg intravenously

Zofran 8 mg DRUG

intravenous administration of 8 mg ondansetron

Ondansetron 8 mg intravenously

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-60 years
• sex: males
• ASA score I or II

You may not qualify if:

• treatment with drugs influencing cardiac repolarization
• coronary artery disease
• heart insufficiency NYHA\>1
• serum electrolyte disturbances
• hypersensitivity to droperidol and/or ondansetron

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdansk

Gdansk, 80-214, Poland

Location

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 9, 2013
• First Posted: March 28, 2013
• Study Start: June 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

PL (1)