Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 4:39 AM
Study NCT ID:
NCT05005494
Status:
UNKNOWN
Last Update Posted:
2021-08-19
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnotic and Anti-nociceptive Components of Magnesium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patient, anesthesiologist and surgeon are blinded'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blinded prospective randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propofol target concentration', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'The target concentration of Propofol TCI (target-control infusion) to achieve a state entropy value between 50-60'}], 'secondaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Morphine consumption titrated in the recovery room and morphine equivalents claimed during the first 24 hours postoperatively'}, {'measure': 'PPI Measure', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'PPI (pupillary pain index) by pupillometry with "AlgiScan®" monitoring, before endotracheal intubation and with a State Entropy of 50-60, then every 5 min between endotracheal intubation and surgical incision'}, {'measure': 'PRD Measure', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'PRD (pupillary reflex dilatation) during laryngoscopy maintained for 30 sec, surgical incision and 10min after surgical incision'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol.', 'detailedDescription': 'The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol. To achieve this, the investigators will analyse the effect of magnesium on the brain concentrations of propofol required to achieve a State Entropy value between 50-60, which corresponds to the recommended depth of anaesthesia. Our study will also evaluate the intraoperative anti- nociceptive effect of magnesium using pupillometry and its two indices, PPI and PRD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult \\> 18 years\n* Patients of both sexes\n* Any patient scheduled for thyroidectomy at the University Hospital of Liege\n\nExclusion Criteria:\n\n* Heart failure with left ventricular ejection fraction \\< 35\n* Renal insufficiency (clearance \\< 40 mL/min)\n* Neuromuscular diseases\n* Atrioventricular block\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05005494', 'briefTitle': 'Hypnotic and Anti-nociceptive Components of Magnesium', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Study of the Hypnotic and Anti-nociceptive Components of Magnesium Using Electroencephalogram Spectral Entropy and Pupillometry During Total Intravenous General Anaesthesia', 'orgStudyIdInfo': {'id': 'MG-Entropy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium sulfate IV', 'description': '10 patients scheduled for thyroidectomy', 'interventionNames': ['Drug: Magnesium sulfate IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '10 patients scheduled for thyroidectomy', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Magnesium sulfate IV', 'type': 'DRUG', 'description': 'Infusion of magnesium sulphate 50 mg/kg (eq. 0.5ml/kg of magnesium sulphate 100mg/ml)', 'armGroupLabels': ['Magnesium sulfate IV']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Infusion of NaCl (sodium chloride) 0.9% (placebo eq. 0.5ml/kg of NaCl 0.9%)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liege,', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Pierre-Yves Hardy, MD', 'role': 'CONTACT', 'email': 'pyhardy@chuliege.be', 'phone': '003242844858'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesiology Departement', 'investigatorFullName': 'Jean François Brichant', 'investigatorAffiliation': 'University of Liege'}}}}