Droperidol and Cardiac Repolarization

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01819857

Enrollment

Registered

2013-03-28

Start date

2011-06-30

Completion date

2013-07-31

Last updated

2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Repolarization

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?

Interventions

DRUGXomolix 0.625 mg intravenously

intravenous administration of 0.625 mg droperidol

DRUGXomolix 1.25 mg

intravenous administration of 1.25 mg droperidol

DRUGZofran 8 mg

intravenous administration of 8 mg ondansetron

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value	20 minutes

Secondary

Measure	Time frame
Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms	20 min

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026