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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-05', 'studyFirstSubmitDate': '2013-03-09', 'studyFirstSubmitQcDate': '2013-03-25', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in QT interval value, QTc interval value and transmural dispersion of repolarization (TDR) value', 'timeFrame': '20 minutes'}], 'secondaryOutcomes': [{'measure': 'Number of individuals with QTc increase by 50 ms and TDR increase by 25 ms', 'timeFrame': '20 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Repolarization']}, 'descriptionModule': {'briefSummary': "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.\n\nThe aim of this study was to answer the questions:\n\n6\\. Does droperidol make an significant prolongation of heart repolarisation, expressed as corrected QT interval?\n\n1. Does droperidol cause increase of transmural dispersion of repolarisation?\n2. Does possible torsadogenic acting of droperidol depend on dose of drug?\n3. Does ondansetron cause changes of electrical heart function, suggesting its possibilities to induce TdP tachycardia?\n4. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in people not suffering from cardiovascular diseases?"}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-60 years\n* sex: males\n* ASA score I or II\n\nExclusion Criteria:\n\n* treatment with drugs influencing cardiac repolarization\n* coronary artery disease\n* heart insufficiency NYHA\\>1\n* serum electrolyte disturbances\n* hypersensitivity to droperidol and/or ondansetron'}, 'identificationModule': {'nctId': 'NCT01819857', 'briefTitle': 'Droperidol and Cardiac Repolarization', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'The Influence of Droperidol on Cardiac Repolarization. A Double-blind, Ondansetron-controlled Study.', 'orgStudyIdInfo': {'id': 'RO4'}, 'secondaryIdInfos': [{'id': 'MUG4', 'type': 'OTHER', 'domain': 'Medical University of Gdansk'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Droperidol 0.625 mg intravenously', 'interventionNames': ['Drug: Xomolix 0.625 mg intravenously']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Droperidol 1.25 mg intravenously', 'interventionNames': ['Drug: Xomolix 1.25 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ondansetron 8 mg intravenously', 'interventionNames': ['Drug: Zofran 8 mg']}], 'interventions': [{'name': 'Xomolix 0.625 mg intravenously', 'type': 'DRUG', 'description': 'intravenous administration of 0.625 mg droperidol', 'armGroupLabels': ['Droperidol 0.625 mg intravenously']}, {'name': 'Xomolix 1.25 mg', 'type': 'DRUG', 'description': 'intravenous administration of 1.25 mg droperidol', 'armGroupLabels': ['Droperidol 1.25 mg intravenously']}, {'name': 'Zofran 8 mg', 'type': 'DRUG', 'description': 'intravenous administration of 8 mg ondansetron', 'armGroupLabels': ['Ondansetron 8 mg intravenously']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Radoslaw Owczuk', 'investigatorAffiliation': 'Medical University of Gdansk'}}}}