Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-28 @ 2:22 PM
Study NCT ID:
NCT02319161
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2014-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Calcium Channel Blockers and Beta Blockers on Tourniquet-induced Hypertension During Intravenous Regional Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002121', 'term': 'Calcium Channel Blockers'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}, {'id': 'C036604', 'term': 'esmolol'}], 'ancestors': [{'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000077264', 'term': 'Calcium-Regulating Hormones and Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-13', 'studyFirstSubmitDate': '2014-12-13', 'studyFirstSubmitQcDate': '2014-12-13', 'lastUpdatePostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in blood pressure', 'timeFrame': '2 hours'}], 'secondaryOutcomes': [{'measure': 'Decrease in pain', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intravenous regional anesthesia'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to investigate the efficacy of calcium channel blockers and beta blockers for controlling tourniquet induced blood pressure increase in patients undergoing carpal tunnel operations with IVRA. For this purpose files of patients undergoing operation under IVRA were retrospectively examined in terms of demographical and hemodynamic variables.', 'detailedDescription': 'After approval of the University Research Ethics Committee, the files of patients who have been operated under intravenous regional anesthesia (IVRA) in orthopedics clinics between January 2009 and January 2010 were retrospectively investigated. A total of 312 patients, 164 patients with carpal tunnel syndrome and 148 patients with trigger finger have been operated under IVRA. Out of 164 patients who have been operated due to carpal tunnel syndrome, 50 patients in which either calcium channel blockers or beta blockers were used for treatment of critical blood pressure increase after tourniquet inflation and in which whole data were obtained, were included to the study.The patients with systolic blood pressure above to 150 mmHg following tourniquet inflation and in which bolus dose of diltiazem 10 mg (Group I) or calcium channel blocker 0.5mg/kg (Group II) have been administered by intravenous route constituted the study groups. Demographical characteristics and hemodynamic parameters were recorded from the patient files.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The files of patients who were operated on under intravenous regional anesthesia (IVRA) in orthopedics clinics between January 2009 and January 2010 were retrospectively investigated. A total of 312 patients, 164 patients with carpal tunnel syndrome and 148 patients with trigger finger were operated on under IVRA. Out of 164 patients who were operated on due to carpal tunnel syndrome, 50 patients in which either calcium channel blockers or beta blockers were used for treatment of critical blood pressure increase after tourniquet inflation and in which whole data were obtained, were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients operated due to carpal tunnel syndrome under intravenous regional anesthesia betweem January 2009 and January 2010.\n\nExclusion Criteria:\n\nThe patients that the files could not be reached'}, 'identificationModule': {'nctId': 'NCT02319161', 'briefTitle': 'Comparison of Calcium Channel Blockers and Beta Blockers on Tourniquet-induced Hypertension During Intravenous Regional Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Comparison of Calcium-channel Blockers and Beta Blockers in Tourniquet-induced Hypertension During Intravenous Regional Anesthesia', 'orgStudyIdInfo': {'id': '04-130-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Group I: the patients with systolic blood pressure above to 150 mmHg following tourniquet inflation and in which bolus dose of calcium channel blocker 10 mg was administered by intravenous route.', 'interventionNames': ['Drug: Calcium channel blocker and beta blocker']}, {'label': 'Group II', 'description': 'Group II: the patients with systolic blood pressure above to 150 mmHg following tourniquet inflation and in which bolus dose of beta blocker 0.5mg/kg was administered by intravenous route', 'interventionNames': ['Drug: Calcium channel blocker and beta blocker']}], 'interventions': [{'name': 'Calcium channel blocker and beta blocker', 'type': 'DRUG', 'otherNames': ['Diltizem , Brevibloc'], 'description': 'The patients in which systolic blood pressure increased to 150 mmHg and above following tourniquet inflation and in which a bolus dose of calcium channel blocker 10 mg (Diltizem, Mustafa Nevzat İlaç Sanayi Aş) (Group I) or beta blocker 0.5mg/kg (Brevibloc, Eczacıbaşı İlaç Sanayi Aş) (Group II) were administered intravenously constituted the study groups.', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'K. Sanem Çakar Turhan, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University Medical Faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Sanem Cakar Turhan', 'investigatorAffiliation': 'Ankara University'}}}}