Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-26 @ 11:37 PM
Study NCT ID:
NCT05858957
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulphate and Extubation Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'extubation quality scores', 'timeFrame': 'at the time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).', 'description': 'Extubation quality will assess with quality scores such as no cough, Mild cough, moderate cough, severe cough.'}], 'secondaryOutcomes': [{'measure': 'extubation time', 'timeFrame': 'time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).', 'description': 'The time need to adequate spontaneous ventilation at recovery period'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Complication']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to search effect of magnesium Sulfate on extubation quality scores, recovery and pain in larynx micro surgery. The patients allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Extubation quality scores, Extubation time, NRS scores were assessed.', 'detailedDescription': 'The investigators aimed to search effect of magnesium sulfate on extubation quality, recovery feature and complications.98 adult patients scheduled for larynx laser microsurgery were included and randomly allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Paracetamol 15 mg/kg applied to all patients.Extubation quality score, extubation time, stay in postanesthesia unit (PACU) time, numeric rating scale (NRS) and complications were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 age over\n* American society of Anesthesiology (ASA) clinical status I-III\n* the patients who experience larynx micro surgery\n\nExclusion Criteria:\n\n* under 18 years old\n* ASA IV and over\n* severe airway obstruction\n* neuromuscular disease\n* presence of tracheostomy'}, 'identificationModule': {'nctId': 'NCT05858957', 'briefTitle': 'Magnesium Sulphate and Extubation Quality', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'The Effect of Magnesium Sulfate on Extubation Quality Score and Recovery in Larynx Laser Microsurgery, Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'Extubation quality'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium', 'description': 'Magnesium sulfate 30 mg/kg with 100 ml saline will apply in 10 min before induction of general anesthesia (maximum magnesium dose 2g) (Group M) . When the magnesium infusion completed, general anesthesia induction will start.', 'interventionNames': ['Drug: Magnesium sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline', 'description': 'saline 100 ml will apply in 10 min before induction of general anesthesia (Group S) . When the saline infusion completed, general anesthesia induction will start.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Magnesium sulfate', 'type': 'DRUG', 'otherNames': ['Intravenous magnesium infusion'], 'description': 'magnesium sulphate IV 30 mg/kg (10 min) infusion apply to the Group M', 'armGroupLabels': ['Magnesium']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Saline infusion'], 'description': '100 ml saline infusion apply to the Group S', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01380', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'ebru biricik', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'çukurova university faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'ebru biricik', 'investigatorAffiliation': 'Cukurova University'}}}}