Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-08 @ 5:54 AM
Study NCT ID:
NCT01041066
Status:
UNKNOWN
Last Update Posted:
2009-12-31
First Post:
2009-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicardipine Versus Labetalol During Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2010-09-27', 'releaseDate': '2010-09-07'}], 'estimatedResultsFirstSubmitDate': '2010-09-07'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D007741', 'term': 'Labetalol'}, {'id': 'D009529', 'term': 'Nicardipine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012457', 'term': 'Salicylamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2009-12-30', 'studyFirstSubmitDate': '2009-12-30', 'studyFirstSubmitQcDate': '2009-12-30', 'lastUpdatePostDateStruct': {'date': '2009-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemodynamic variables (systolic blood pressure, diastolic blood pressure and mean blood pressure, heart rate)', 'timeFrame': 'preinduction- 10 min after intubation'}]}, 'conditionsModule': {'keywords': ['patients who are intubated for general anesthesia'], 'conditions': ['Patients Who Are Intubated for General Anesthesia', 'Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '22364823', 'type': 'DERIVED', 'citation': 'Ryu JH, Apfel CC, Whelan R, Jeon YT, Hwang JW, Do SH, Ro YJ, Kim CS. Comparative prophylactic and therapeutic effects of intravenous labetalol 0.4 mg/kg and nicardipine 20 mug/kg on hypertensive responses to endotracheal intubation in patients undergoing elective surgeries with general anesthesia: a prospective, randomized, double-blind study. Clin Ther. 2012 Mar;34(3):593-604. doi: 10.1016/j.clinthera.2012.01.017. Epub 2012 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the efficacy of nicardipine and labetalol in attenuation of cardiovascular responses to endotracheal intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for general anesthesia with endotracheal intubation\n\nExclusion Criteria:\n\n* Patients with heart failure or coronary artery disease 2-3 degree atrio-ventricular block or severe bradycardia (\\< 45 beats/min) asthma, bronchial spasm or chronic obstructive pulmonary disease patients with anticipated difficult intubation (Mallampati class III, IV) severe hepatic or renal dysfunction allergy or contraindication to study medication'}, 'identificationModule': {'nctId': 'NCT01041066', 'briefTitle': 'Nicardipine Versus Labetalol During Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'orgStudyIdInfo': {'id': 'nicardipine-labetalol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group L', 'description': '0.4 mg/kg labetalol', 'interventionNames': ['Drug: labetalol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group N', 'description': '20 ㎍/kg nicardipine', 'interventionNames': ['Drug: nicardipine']}], 'interventions': [{'name': 'labetalol', 'type': 'DRUG', 'description': '0.4 mg/kg labetalol intravenously 4 min before intubation', 'armGroupLabels': ['group L']}, {'name': 'nicardipine', 'type': 'DRUG', 'description': '20 ㎍/kg nicardipine intravenously 4 min before intubation', 'armGroupLabels': ['group N']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-Hee Ryu, Ph.D', 'role': 'CONTACT', 'email': 'jinaryu@lycos.co.kr', 'phone': '82-31-787-7497'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Jung-Hee Ryu, Ph.D', 'role': 'CONTACT', 'email': 'jinaryu@lycos.co.kr', 'phone': '82-31-787-7497'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Seoul National University Bundang Hospital', 'oldOrganization': 'Seoul National University Bundang Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2010-09-07', 'type': 'RELEASE'}, {'date': '2010-09-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Seoul National University Bundang Hospital (Seoul National University Bundang Hospital)'}}}}