Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT02732093
Status:
UNKNOWN
Last Update Posted:
2016-04-08
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Stellate Ganglion Block Decrease Stress Response of Intubation?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'heart rate', 'timeFrame': '5 minutes', 'description': 'measured in beat/min.'}], 'secondaryOutcomes': [{'measure': 'mean arterial blood pressure', 'timeFrame': '5 minutes', 'description': 'measured in mm.Hg'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intubation', 'Stellate Ganglion']}, 'descriptionModule': {'briefSummary': 'In this study investigators will evaluate the effect of stellate ganglion block on stress response of intubation in comparison to traditional antistress measures in adult patients', 'detailedDescription': 'Both groups will have the same general anesthesia procedure, patients in stellate block group will receive lidocaine in the stellate block will in control group patients will receive Na.Cl as placebo. primary outcome will be stress response to subsequent endotracheal intubation measure by changes in heart rate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgery\n* General anesthesia with endotracheal intubation\n* ASA I/II\n\nExclusion Criteria:\n\n* Pregnancy\n* Hypersensitivity to local anesthetics\n* Coagulopathy\n* Infection at site of injection\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT02732093', 'briefTitle': 'Does Stellate Ganglion Block Decrease Stress Response of Intubation?', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Does Stellate Ganglion Block Decrease Stress Response of Intubation?', 'orgStudyIdInfo': {'id': 'irb00008718/654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stellate block', 'description': 'patients in this arm will receive ultrasonographic guided left stellate block with 6 ml of lidocaine 2% after routine induction of general anesthesia and before endotracheal intubation', 'interventionNames': ['Procedure: stellate block', 'Drug: lidocaine 2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'patients in this arm will receive ultrasonographic guided left stellate block with 6 ml normal saline (Na.Cl 0.9%) (control group) after routine induction of general anesthesia and before endotracheal intubation', 'interventionNames': ['Procedure: stellate block', 'Drug: Na.Cl 0.9% (placebo)']}], 'interventions': [{'name': 'stellate block', 'type': 'PROCEDURE', 'otherNames': ['cervicothoracic ganglion block'], 'armGroupLabels': ['control', 'stellate block']}, {'name': 'Na.Cl 0.9% (placebo)', 'type': 'DRUG', 'armGroupLabels': ['control']}, {'name': 'lidocaine 2%', 'type': 'DRUG', 'armGroupLabels': ['stellate block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'contacts': [{'name': 'abdelraheem Elawamy, MD', 'role': 'CONTACT', 'email': 'arawamyyy@yahoo.com', 'phone': '00201000032655'}], 'facility': 'Assiut University hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Abdelraheem Elawamy, MD', 'role': 'CONTACT', 'email': 'arawamyyy@yahoo.com', 'phone': '00201000032655'}], 'overallOfficials': [{'name': 'abdelraheem Elawamy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'abdelraheem elawamy', 'investigatorAffiliation': 'Assiut University'}}}}