Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05301127
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2022-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery
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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-13', 'studyFirstSubmitDate': '2022-03-19', 'studyFirstSubmitQcDate': '2022-03-19', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': '24 hours', 'description': 'postoperative morphine consumption'}], 'secondaryOutcomes': [{'measure': 'Postoperative patient satisfaction', 'timeFrame': '24 hours', 'description': '1 = very unsatisfactory; 2 = unsatisfactory; 3 = indifferent; 4 = satisfactory; and 5 = very satisfactory.'}, {'measure': 'Intraoperative surgeon satisfaction.', 'timeFrame': '6 hours', 'description': 'using 1-4 scales (1, bad; 2, moderate; 3, good; 4, excellent;'}, {'measure': 'Incidence of complications', 'timeFrame': '24 hours', 'description': 'such as hypotension, bradycardia, nausea and vomiting, postoperative shivering,'}, {'measure': 'Blood loss', 'timeFrame': '6 hours', 'description': 'intraoperative Blood loss'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Combination of General Anesthesia to Spinal and Epidural Techniques']}, 'descriptionModule': {'briefSummary': 'The combination of general anesthesia to spinal and epidural techniques (CSEGA) proved to have a synergistic effect, thus, the use of sub-anesthetic doses can provide satisfactory anesthetic and analgesic results. CSEGA has several known advantages including appropriate postoperative analgesia, shows some benefit in the intraoperative blood loss control causing a decreased need for blood transfusion, rapid regain of the gastrointestinal actions and decreases the incidence of postoperative respiratory complications. Unfortunately, the drawbacks of using neuro-axial anesthesia in combination to general anesthesia will be not thoroughly introduced in many researches, thus, remain unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Inclusion criteria:\n\n * Patients aged from 18 to50 years.\n * ASA I-II.\n * undergoing elective liposuction surgery\n * BMI from 25 to 40 kg/m2\n2. Exclusion criteria:\n\n * Patient refusal\n * ASA III-IV.\n * Patients aged less than 18 or more than 50.\n * Body mass index \\>40.\n * Any contraindications to neuro-axial block such as coagulopathy or spine deformity\n * Chronic opioid consumption,\n * History of parenteral or oral analgesic intake within the last 48hours.'}, 'identificationModule': {'nctId': 'NCT05301127', 'briefTitle': 'Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery', 'orgStudyIdInfo': {'id': 'N-54-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CSEGA group', 'description': 'Will be received combined spinal-epidural-general anesthesia.', 'interventionNames': ['Device: spinal-epidural device']}, {'type': 'NO_INTERVENTION', 'label': 'GA group', 'description': 'will be received general anesthesia only.'}], 'interventions': [{'name': 'spinal-epidural device', 'type': 'DEVICE', 'description': 'received combined spinal-epidural-general anesthesia.', 'armGroupLabels': ['CSEGA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still working'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, Pain management and Surgical ICU', 'investigatorFullName': 'Amr Samir Wahdan', 'investigatorAffiliation': 'Cairo University'}}}}