Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT06300658
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2024-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula flow rate', 'timeFrame': '7th day postoperatively', 'description': 'Flow rate will be measured on the first day postoperative then on the 7th day.'}], 'secondaryOutcomes': [{'measure': 'Peak systolic velocity (PSV)', 'timeFrame': '7th day postoperatively', 'description': 'Peak systolic velocity (PSV) will be measured from radial artery 2 cm. proximal to fistula site, on the first day postoperative then on the 7th day.'}, {'measure': 'End diastolic velocity (EDV)', 'timeFrame': '7th day postoperatively', 'description': 'End diastolic velocity (EDV) will be measured from radial artery 2 cm. proximal to fistula site, on the first day postoperative then on the 7th day.'}, {'measure': 'Incidence of failure', 'timeFrame': '7th day postoperatively', 'description': 'Incidence of failure will be measured on the first day postoperative then on the 7th day.'}, {'measure': 'Adverse effects', 'timeFrame': '7th day postoperatively', 'description': 'Postoperative adverse reactions such as hematoma, infection, thrombosis, bleeding, and pitosis will be recorded in both groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stellate Ganglion Block', 'Arteriovenous Fistula', 'Hemodialysis', 'Major Lower Limb Orthopedic Surgery']}, 'referencesModule': {'references': [{'pmid': '40450242', 'type': 'DERIVED', 'citation': 'Eldemrdash AM, Hammad SS, Hemaida TS, Dardeer TT, Mohsen AA, Fathy AK, Shams GH. Stellate ganglion block for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgeries: randomized control trial. BMC Anesthesiol. 2025 May 31;25(1):277. doi: 10.1186/s12871-025-03150-7.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery.', 'detailedDescription': 'The best way for dialysis in chronic renal failure (CRF) patients with consideration of feasibility, rate of infection, and patency is hemodialysis by using native access by using arteriovenous fistula (AVF).\n\nAltered calcium and phosphor metabolism in CRF patients would also increase vascular reactivity. Stellate ganglion blockade (SGB) has been used for several years for both diagnosis and treatment of circulatory problems in upper extremity. Recently preemptive SGB has been used in prevention of radial artery spasm in coronary artery patients.\n\nSGB increases blood flow and decrease vascular resistance in the arm. SGB prevents or ameliorates the reactivity of the muscular layer of the RA in response to both surgical manipulation during harvesting the artery and to the potent vasoconstrictor mediators released during surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 to 75 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) physical status III.\n* Chronic renal failure (CRF) patients.\n* Undergoing major lower limb orthopedic surgery.\n\nExclusion Criteria:\n\n* Psychiatric disorders.\n* History of substance abuse.\n* Ipsilateral brachial and radial artery stenosis.\n* Allergy to local anesthetics.\n* Cardiovascular and respiratory disorders.\n* Coagulopathy.\n* Use of vasoactive medications.\n* Obesity (body mass index \\>30 kg/m2).\n* Smoking.'}, 'identificationModule': {'nctId': 'NCT06300658', 'briefTitle': 'Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University'}, 'officialTitle': 'Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '900/2/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stellate ganglion blockade', 'description': 'Patient will receive preemptive stellate ganglion blockade (SGB) just before spinal anesthesia.', 'interventionNames': ['Drug: Stellate ganglion block']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patient will not receive preemptive stellate ganglion blockade (SGB).'}], 'interventions': [{'name': 'Stellate ganglion block', 'type': 'DRUG', 'description': 'Patient will receive preemptive stellate ganglion block (SGB) just before spinal anesthesia.', 'armGroupLabels': ['Stellate ganglion blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'state': 'Aswan Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ayman M Eldemrdash, MD', 'role': 'CONTACT', 'email': 'ayman.mohamady@aswu.edu.eg', 'phone': '00201001296116'}, {'name': 'Soudy S Hammad, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tarek S Hemaida, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Taha T Dardeer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed A Mohsen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed K Fathy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gamal H Shams, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Aswan University', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'Ayman M Eldemrdash, MD', 'role': 'CONTACT', 'email': 'ayman.mohamady@aswu.edu.eg', 'phone': '00201001296116'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Aswan University, Egypt', 'investigatorFullName': 'Ayman Mohamady Eldemrdash', 'investigatorAffiliation': 'Aswan University'}}}}