Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-05 @ 1:28 PM
Study NCT ID:
NCT03436368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2018-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Spinal Anesthesia in Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Using computer \\& sealed envelope randomization, patients are assigned to receive either continuous spinal anesthesia \\[CSA group: n =30\\] or general anesthesia \\[GA group: n=30\\]'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean ABP', 'timeFrame': '12 hours', 'description': 'Change in Mean Arterial Blood Pressure measured in mmHg.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Score for pain "VAS"', 'timeFrame': '12 hours', 'description': 'Visual Analogue Score for pain measures the degree of pain experienced by the patient during the procedure. VAS is graded from 0-10 \\[where 0=no pain, 10= worst pain\\].'}, {'measure': 'Patient satisfaction score', 'timeFrame': '24 hours', 'description': 'Patient satisfaction Score defines the degree of patient satisfaction with the anesthetic experience and is assessed after recovery. It is graded as excellent "E" (best score), fair "F" or poor "P" (worst score).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continuous spinal anesthesia', 'General anesthesia', 'Renal transplantation', 'Chronic renal failure'], 'conditions': ['Renal Failure Chronic', 'Transplant;Failure,Kidney', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Renal transplantation is now recognized as a treatment of choice for patients with end-stage renal disease. An adequate anesthetic technique should achieve hemodynamic stability and enhance perfusion of the transplanted kidney. The aim of this study is to assess the use \\& effects of continuous spinal anesthesia for kidney transplantation recipients, compared with balanced general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA class III or IV\n* End-stage renal disease\n* Renal transplantation candidate patients\n\nExclusion Criteria:\n\n* Any condition contra-indicating regional anesthesia\n* Coagulopathy\n* Allergic to any of the drugs used during the procedure'}, 'identificationModule': {'nctId': 'NCT03436368', 'briefTitle': 'Continuous Spinal Anesthesia in Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Continuous Spinal Anesthesia for Renal Transplant Recipients', 'orgStudyIdInfo': {'id': 'CSARTR60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CSA group', 'description': 'Continuous Spinal Anesthesia', 'interventionNames': ['Procedure: Continuous spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GA group', 'description': 'General Anesthesia', 'interventionNames': ['Procedure: General anesthesia']}], 'interventions': [{'name': 'Continuous spinal anesthesia', 'type': 'PROCEDURE', 'description': 'Continuous spinal anesthesia will be performed for patients of the CSA group at the L3-L4 intervertebral space using Spinocath (B. Braun, Melsungen, Germany). After the cerebrospinal fluid is aspirated, 7.5 mg hyperbaric Bupivacaine 0.5% (1.5 ml) together with 25 micrograms Fentanyl (0.5 ml) will be injected intra-thecally. Supplemental injections will be given in aliquots of 5 mg hyperbaric Bupivacaine 0.5% (1 ml) if the sensory block is lower or reseeds, during surgery, below T6 dermatome.', 'armGroupLabels': ['CSA group']}, {'name': 'General anesthesia', 'type': 'PROCEDURE', 'description': 'Anesthesia will be induced with intra-venous administration of Fentanyl (2 micrograms/kg), Ptopofol (1-2 mg/kg) and Atracurium (0.5 mg/kg). Maintenance will be achieved with 0.8-1.5% Isoflurane in an O2 / air mixture, an Atracurium infusion at 0.5 mg/kg/hr and a Fentanyl infusion at 1 micrograms/kg/hr.', 'armGroupLabels': ['GA group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Al-Ainy Hospital, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Nazmy E Seif, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kasr Al-Ainy Hospital, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nazmy Edward Seif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Nazmy Edward Seif', 'investigatorAffiliation': 'Cairo University'}}}}