Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-30 @ 7:43 AM
Study NCT ID:
NCT04779060
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2021-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Fentanyle Versus Dexamethasone in Gynacological Laparoscopic Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2021-02-27', 'studyFirstSubmitQcDate': '2021-02-27', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative pain', 'timeFrame': '60 minutes', 'description': 'pain measured by VAS score =from 0 to 10 0-3 is mild pain 3-6 moderate pain 6-10 sever pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperativ Pain']}, 'descriptionModule': {'briefSummary': 'Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic technique suitable for laparoscopic interventions, and several myths and facts prevented regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the main aspects of concern which are thought to be best controlled by GA'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I, II\n* elective gynacological laparoscopic surgery\n\nExclusion Criteria:\n\n* patient refusal\n* chronic kidney and hepatic diseases'}, 'identificationModule': {'nctId': 'NCT04779060', 'briefTitle': 'Intrathecal Fentanyle Versus Dexamethasone in Gynacological Laparoscopic Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Intrathecal Fentanyle Versus Dexamethasone in Patients Under Going Gynacological Laparoscopic Surgeries', 'orgStudyIdInfo': {'id': '13700331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyle group', 'interventionNames': ['Drug: intrathecal fentanyle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexamethasone group', 'interventionNames': ['Drug: dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'interventionNames': ['Drug: saline']}], 'interventions': [{'name': 'intrathecal fentanyle', 'type': 'DRUG', 'description': '25 mic fentanyle added to heavy bupivacaine for spinal anesthesia', 'armGroupLabels': ['fentanyle group']}, {'name': 'dexamethasone', 'type': 'DRUG', 'description': '8 mg dexamethasone give intrathecally for spinal anaesthesia', 'armGroupLabels': ['dexamethasone group']}, {'name': 'saline', 'type': 'DRUG', 'description': 'normal saline will be mixed with bupivacaine intrathecally', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia', 'investigatorFullName': 'Rasha Hamed', 'investigatorAffiliation': 'Assiut University'}}}}