Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 10:31 PM
Study NCT ID:
NCT02671227
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2016-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Mg in Gynecologic Laparoscopic Surgeries.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-26', 'studyFirstSubmitDate': '2016-01-24', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgeon satisfaction (scale from 1 to 10) .', 'timeFrame': 'intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure).', 'description': 'surgeon satisfaction (scale from 1 to 10) as 1 is worst and 10 is best.'}], 'secondaryOutcomes': [{'measure': 'postoperative pain management (VAS score).', 'timeFrame': 'postoperative for 6 hours.', 'description': 'Visual Analog Scale (VAS score).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gynecologic Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.', 'detailedDescription': 'The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patient.\n* more than 18 years.\n* undergoing elective gynecologic laparoscopic surgeries.\n\nExclusion Criteria:\n\n* allergy to local anesthesia.\n* contraindication to spinal anesthesia.\n* Significant cardiac, liver or renal dysfunction.\n* Inability to informed consent'}, 'identificationModule': {'nctId': 'NCT02671227', 'briefTitle': 'Intrathecal Mg in Gynecologic Laparoscopic Surgeries.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Surgeon Satisfaction and Postoperative Pain in Gynecologic Laparoscopic Surgeries.', 'orgStudyIdInfo': {'id': 'intrathecal Mg in gyne. lap.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intrathecal bupivacaine + Mg sulfate', 'description': 'intrathecal bupivacaine 15 mg + intrathecal Mg sulfate 50 mg. in gynecologic laparoscopic surgeries.', 'interventionNames': ['Drug: intrathecal Mg sulfate.', 'Drug: intrathecal bupivacaine 15 mg.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intrathecal bupivacaine', 'description': 'intrathecal bupivacaine 15 mg in gynecologic laparoscopic surgeries.', 'interventionNames': ['Drug: intrathecal bupivacaine 15 mg.']}], 'interventions': [{'name': 'intrathecal Mg sulfate.', 'type': 'DRUG', 'description': 'intrathecal Mg sulfate 50 mg.', 'armGroupLabels': ['intrathecal bupivacaine + Mg sulfate']}, {'name': 'intrathecal bupivacaine 15 mg.', 'type': 'DRUG', 'description': 'intrathecal bupivacaine 15 mg.', 'armGroupLabels': ['intrathecal bupivacaine', 'intrathecal bupivacaine + Mg sulfate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asiut', 'country': 'Egypt', 'facility': 'Asiut university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anaesthesia and ICU', 'investigatorFullName': 'khaled salah mohamed', 'investigatorAffiliation': 'Assiut University'}}}}