Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-29 @ 12:22 AM
Study NCT ID:
NCT02037802
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2014-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008614', 'term': 'Meperidine'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pain scoring system (objective behavioural pain score)', 'timeFrame': 'from the time of transfere to the nephrology ICU, every hour for the first 24 hours postoperative'}], 'primaryOutcomes': [{'measure': 'Intraoperative blood pressure', 'timeFrame': 'from the induction of anesthesia till end of surgery at half an hour intervals', 'description': 'measure systolic and diastolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'postoperative blood pressure', 'timeFrame': 'from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours', 'description': 'record systolic and diastolic blood pressure every hour for the first 24 hours postoperative'}, {'measure': 'intraoperative central venous pressure', 'timeFrame': 'fromom the induction of anesthesia till end of surgery at half an hour intervals'}, {'measure': 'postoperative heart rate', 'timeFrame': 'from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours'}, {'measure': 'postoperative central venous pressure', 'timeFrame': 'from the time of transfer of the patient to the intensive care unit at one hour intervals for 24 hours'}, {'measure': 'intraoperative heart rate', 'timeFrame': 'from the induction of anesthesia till end of surgery at half an hour intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['caudal', 'epidural', 'pediatric', 'renal', 'transplant', 'hemodynamics'], 'conditions': ['Renal Failure']}, 'referencesModule': {'references': [{'pmid': '26493396', 'type': 'DERIVED', 'citation': 'Soaida SM, ElSheemy MS, Shouman AM, Shoukry AI, Morsi HA, Salah DM, Fadel FI, Bazaraa HM. Caudal extradural catheterization in pediatric renal transplant and its effect on perioperative hemodynamics and pain scoring: a prospective randomized study. J Anesth. 2016 Feb;30(1):47-54. doi: 10.1007/s00540-015-2087-8. Epub 2015 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. this study emphasises the ease of application of epidural catheter via the caudal route to the lower thoracic level; avoiding possible complications that may arise from lumbar or thoracic routes, and its effects on hemodynamics when using analgesic doses of local anesthetics and narcotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3-12 years\n* end stage renal disease\n* no known allergy to bupivacaine\n* both sexes\n\nExclusion Criteria:\n\n* known allergy to bupivacaine\n* inflammation at caudal area\n* spinal cord deformity'}, 'identificationModule': {'nctId': 'NCT02037802', 'briefTitle': 'Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Caudal Extradural Catheterization in Pediatric Renal Transplant: Effect on Perioperative Hemodynamics and Pain Scoring.', 'orgStudyIdInfo': {'id': 'SMS2014-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'caudal epidural catheterization group', 'description': '30 patients received continuous intra and post-operative caudal epidural infusion of bupivacaine 0.125% with fentanyl (2 microgram/ml) over 24 hours', 'interventionNames': ['Device: B-Braun, Perifix® ONE Paed, Germany', 'Drug: Pethidine', 'Drug: Propofol', 'Drug: Bupivacaine', 'Drug: Fentanyl']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': "30 patients didn't receive caudal epidural analgesia", 'interventionNames': ['Drug: Pethidine', 'Drug: Propofol', 'Drug: Fentanyl']}], 'interventions': [{'name': 'B-Braun, Perifix® ONE Paed, Germany', 'type': 'DEVICE', 'description': 'caudal epidural catheterization bupivacaine fentanyl', 'armGroupLabels': ['caudal epidural catheterization group']}, {'name': 'Pethidine', 'type': 'DRUG', 'description': 'pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia', 'armGroupLabels': ['caudal epidural catheterization group', 'control group']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'fentanyl propofol atracurium besylate', 'armGroupLabels': ['caudal epidural catheterization group', 'control group']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'armGroupLabels': ['caudal epidural catheterization group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'armGroupLabels': ['caudal epidural catheterization group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of medicine, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sherif M Soaida, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Sherif Mohamed Abd el moneim Soaida, MD', 'investigatorAffiliation': 'Cairo University'}}}}