MedDataX Logo

Droperidol and Cardiac Repolarization

NCT ID: NCT01819857

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Repolarization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Droperidol 0.625 mg intravenously

Group Type ACTIVE_COMPARATOR

Xomolix 0.625 mg intravenously

Intervention Type DRUG

intravenous administration of 0.625 mg droperidol

Droperidol 1.25 mg intravenously

Group Type ACTIVE_COMPARATOR

Xomolix 1.25 mg

Intervention Type DRUG

intravenous administration of 1.25 mg droperidol

Ondansetron 8 mg intravenously

Group Type ACTIVE_COMPARATOR

Zofran 8 mg

Intervention Type DRUG

intravenous administration of 8 mg ondansetron

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Xomolix 0.625 mg intravenously

intravenous administration of 0.625 mg droperidol

Intervention Type DRUG

Xomolix 1.25 mg

intravenous administration of 1.25 mg droperidol

Intervention Type DRUG

Zofran 8 mg

intravenous administration of 8 mg ondansetron

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Radoslaw Owczuk

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Gdansk

Gdansk, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MUG4

Identifier Type: OTHER

Identifier Source: secondary_id

RO4

Identifier Type: -

Identifier Source: org_study_id