Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-03-13 @ 9:22 PM
Study NCT ID:
NCT01548859
Status:
UNKNOWN
Last Update Posted:
2012-03-08
First Post:
2012-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Sevoflurane and Midazolam Used for the Maintenance of Anaesthesia on the Levels of Postoperative Cardiac Troponin I in Pediatric Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-06', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'myocardial protective effect of sevoflurane', 'timeFrame': 'postoperative 48 hours', 'description': 'Postoperative troponin I levels'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic and respiratory data', 'timeFrame': 'Postoperative 48 hours', 'description': 'Arterial pressure, heart rate, blood gas analysis, extubation time,'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial protection', 'Myocardial injury', 'Anaesthetic preconditioning', 'Pediatric cardiac surgery', 'Troponin I', 'Sevoflurane', 'Midazolam'], 'conditions': ['Myocardial Injury', 'Anaesthetic Preconditioning']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two different anaesthetic agent effect on postoperative Troponin I levels in pediatric cardiac surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective pediatric surgery\n* Patients written informed consent for study participation\n\nExclusion Criteria:\n\n* Redo surgery\n* History of myocarditis\n* Renal failure\n* Pulmonary embolism\n* Hypothyroidism'}, 'identificationModule': {'nctId': 'NCT01548859', 'briefTitle': 'Comparison of the Effects of Sevoflurane and Midazolam Used for the Maintenance of Anaesthesia on the Levels of Postoperative Cardiac Troponin I in Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'orgStudyIdInfo': {'id': 'KA 11/60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'description': 'Used for maintenance anaesthesia (0.2 mg/kg/saat continuous infusion)', 'interventionNames': ['Drug: Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane', 'description': 'Used for the maintenance for anaesthesia (% 0.5-8 end tidal concentration)', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': '0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia', 'armGroupLabels': ['Midazolam']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'end tidal concentration of % 0,5-8', 'armGroupLabels': ['Sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University, Faculty of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anaesthesiology Resident', 'investigatorFullName': 'Huseyin Utku YILDIRIM', 'investigatorAffiliation': 'Baskent University'}}}}