Droperidol and Cardiac Repolarization | NCT01819857

Studies
Droperidol and Cardiac Repolarization

NCT01819857

Sponsor

Medical University of Gdansk

Status

Completed

Last Update Posted

Aug 7, 2013Estimated

Enrollment

75Estimated

Phase

Phase 4

Conditions

Cardiac Repolarization

Interventions

Xomolix 0.625 mg intravenously
Xomolix 1.25 mg
Zofran 8 mg

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MUG4	Other Identifier	Medical University of Gdansk

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 9, 2013

First Submission Date that Met QC Criteria

Mar 25, 2013

First Posted Date

Mar 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2013

Last Update Posted Date

Aug 7, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Radoslaw Owczuk, Principle Investigator, Medical University of GdanskPrincipal Investigator

Lead Sponsor

Medical University of GdanskOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Xomolix 0.625 mg intravenously	Drug	intravenous administration of 0.625 mg droperidol	Droperidol 0.625 mg intravenously

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Gdansk		Gdansk		80-214	Poland

Intervention Browse Module

MeSH Terms

ID	Term
D017294	Ondansetron

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

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Browse Branches

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