Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-21 @ 10:01 PM
Study NCT ID:
NCT01606969
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2012-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2012-05-20', 'studyFirstSubmitQcDate': '2012-05-25', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial pressure', 'timeFrame': 'before and after scalp injection', 'description': 'before scalp injection(T0), after scalp injection every half minute until five minutes(T0.5, T1, T1.5, T2, T2.5, T3, T3.5, T4, T4.5, T5), every minute(T6, T7, T8, T9, T10, T11, T12, T13, T14, T15)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'epinephrine', 'lidocaine', 'scalp infiltration', 'craniotomy'], 'conditions': ['Craniotomy']}, 'descriptionModule': {'briefSummary': 'Scalp infiltration with Epinephrine- containing lidocaine solution is common method for craniotomy but it may result in transient but significant hypotension in patients undergoing neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during scalp incision in craniotomy.\n\nThe aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* Aged between 20 and 70 year\n* general anesthesia for craniotomy\n\nExclusion Criteria:\n\n* Congestive heart failure, coronary artery occlusive disease\n* Bradycardia \\< 50 BPM, 2nd degree \\< AV block\n* Poorly controlled hypertension\n* ß blocker medication\n* Coagulopathy\n* Pregnancy, nursing'}, 'identificationModule': {'nctId': 'NCT01606969', 'briefTitle': 'Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Randomized Controlled Trial to Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution for the Effect on Hemodynamic Response Due to Scalp Infiltration in Patients Undergoing Craniotomy', 'orgStudyIdInfo': {'id': '4-2012-0062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dex group', 'description': 'dexmedetomidine-lidocaine solution,', 'interventionNames': ['Drug: scalp infiltration solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'epinephrine-lidocaine solution', 'interventionNames': ['Drug: scalp infiltration solution']}], 'interventions': [{'name': 'scalp infiltration solution', 'type': 'DRUG', 'description': 'Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)', 'armGroupLabels': ['Dex group']}, {'name': 'scalp infiltration solution', 'type': 'DRUG', 'description': '1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}