Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT06848595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cerebral desaturation events.', 'timeFrame': 'intraoperative'}], 'secondaryOutcomes': [{'measure': 'Duration of cerebral desaturation events', 'timeFrame': 'intraoperative'}, {'measure': 'change in heart rate in beats', 'timeFrame': 'intraoperative'}, {'measure': 'change in blood pressure in mmHg', 'timeFrame': 'Intraoperative'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Desaturation Events', 'Spine Surgeries']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the effects of dexmedetomidine and magnesium sulfate on cerebral oxygen saturation in patients undergoing spine surgeries as adjuvant to general anesthesia guided by cerebral oximetry. The main aims to are Incidence of cerebral desaturation events and duration of cerebral desaturation events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 21 to 60 years old.\n* either gender.\n* American Society of Anesthesiologists (ASA) physical status I and II.\n\nExclusion Criteria:\n\n* Patient refusal to participate in research.\n* History of preoperative neuromuscular disease.\n* Patients with preexisting cerebral pathology (such as previous episodes of cerebral ischemia or stroke).\n* History of psychiatric illness.\n* History of orthostatic hypotension, myocardial infarction, uncontrolled hypertension or documented carotid stenosis.\n* Coagulopathy disorder.\n* Patients receiving magnesium supplementation.\n* Chronic use of opioids.\n* Current treatment with a β-blocker or calcium channel blocker.'}, 'identificationModule': {'nctId': 'NCT06848595', 'acronym': 'mg/dex/rSO2', 'briefTitle': 'Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effects of Dexmedetomidine Versus Magnesium Sulfate on Cerebral Oxygen Saturation During Spine Surgery: a Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '36265MD317/11/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MgSO4', 'description': 'loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery.', 'interventionNames': ['Procedure: spine surgery', 'Drug: Magnesium sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dex.', 'description': 'Patients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery.', 'interventionNames': ['Procedure: spine surgery', 'Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'Patients will receive the same volume of normal saline.', 'interventionNames': ['Procedure: spine surgery', 'Drug: Normal Saline (0.9% NaCl)']}], 'interventions': [{'name': 'spine surgery', 'type': 'PROCEDURE', 'description': 'spine surgery in prone position', 'armGroupLabels': ['MgSO4', 'control', 'dex.']}, {'name': 'Magnesium sulfate', 'type': 'DRUG', 'description': 'Patients will receive loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery.', 'armGroupLabels': ['MgSO4']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Patients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery.', 'armGroupLabels': ['dex.']}, {'name': 'Normal Saline (0.9% NaCl)', 'type': 'DRUG', 'description': 'Patients will receive the same volume of normal saline.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ibrahim Elsayed Elnefiawy, assisstant lectuerer', 'role': 'CONTACT', 'email': 'aborazan171@gmail.com', 'phone': '00201001515007'}, {'name': 'Nadia Elsayed Elafify, assistant lectuerer', 'role': 'CONTACT', 'email': 'nadiaelsayed225@gmail.com', 'phone': '0020110627640'}], 'overallOfficials': [{'name': 'Ahmed Said Elgebaly, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University'}, {'name': 'Shimaa Farouk Abdelkader, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Ibrahim Elsayed', 'investigatorAffiliation': 'Tanta University'}}}}