Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-01 @ 10:36 AM
Study NCT ID:
NCT01819857
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2013-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Droperidol and Cardiac Repolarization
Sponsor:
Medical University of Gdansk
Organization:
Study Overview
Official Title:
The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
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?
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MUG4 | OTHER | Medical University of Gdansk | View |