Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT03406403
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2017-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017214', 'term': 'Laryngeal Masks'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008397', 'term': 'Masks'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The patients will be randomized into three equal groups. 60 slips of papers will be taken and labeled as group L (LMA), group M (Magnesium sulphate) and group C (Control). These slips will be placed in an envelope and one slip will be raised for each patient.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We hypothesize that the LMA is more effective than Magnesium sulphate in attenuating systemic stress response during emergence of patients undergoing supratentorial tumours'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-03', 'studyFirstSubmitDate': '2017-12-26', 'studyFirstSubmitQcDate': '2018-01-19', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial blood presure', 'timeFrame': '5 minutes from closure of anesthetics until 15 minutes after extubation', 'description': 'Total dose of nitroglycerin needed in each group to maintain mean blood pressure within 20 % of basal line.'}], 'secondaryOutcomes': [{'measure': 'Intracranial pressure Measurement', 'timeFrame': '1 and 10 minutes after extubation.', 'description': 'Intracranial pressure will be measured at these moments: basal line preinduction, end of surgery, before extubation and 1, 10 minutes after extubation.'}, {'measure': 'Quality of extubation', 'timeFrame': 'Time Onset of cough immediately after extubation', 'description': 'Qualityof extubation will be evaluated based on cough immediately after extubation, using a five point rating scale'}, {'measure': 'Level of consciousness', 'timeFrame': '5 and 15 minutes after extubation', 'description': 'consciousness level will be recorded based on Ramasy score scale at 5 and 15 minutes after extubation, using the following indices'}, {'measure': 'End of surgery and extubation', 'timeFrame': 'intraoperative', 'description': 'Time interval between end of surgery and extubation in each group'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['LMA Versus Mgso4 in Attenuating Stress Response During Emergence of Supratentorial Tumours Patients']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of replacement of ETT with LMA and administration of Magnesium sulphate at the end of the surgery in attenuating systemic stress response during emergence of patients undergoing supratentorial tumours', 'detailedDescription': 'Rapid recovery from neuroanesthesia and early neurological examination are desirable in most cases.(1)Although, Systemic and cerebral hemodynamic changes caused by extubation and emergence from anesthesia may endanger neurosurgical patients and increase the risk of postoperative intracranial hemorrhage and cerebral edema and may even result in the requirement of reoperation.(2) During this phase, heart rate and arterial blood pressure increase leading to increases in cerebral blood flow and intracranial pressure.(3) Some studies have reported such hemodynamic effects in up to 50% of patients after supratentorial craniotomy.(4,5) Replacing the endotracheal tube (ETT) with laryngeal mask airway (LMA) prior to emergence from anesthesia is safe and effectively reduces the cardiovascular response.(6) The potential protective benefit of this approach has not yet been demonstrated for awakening neurosurgery patients, however.\n\nMagnesium is the forth most abundant cation in the body and the second most abundant intracellular cation. It activates many of the enzyme systems.(7) Magnesium sulphate inhibits catecholamines release from adrenergic nerve terminals and from adrenal medulla, through blocking N-type of Ca-channel at peripheral sympathetic nerve ending so it is used to decrease the adverse cardiovascular effects during larygeoscopy and endotracheal intubation.(8) But its role in attenuating stress response during extubation is not well studied and need more research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA physical status I, II.\n2. Ages between 18 and 60 years.\n3. Body mass index (BMI) \\< 30.\n4. Elective surgery\n\nExclusion Criteria:\n\n1. Patients have cardiovascular, pulmonary, renal, hepatic and endocrine diseases.\n2. Patients have any degree of disturbed conscious level.\n3. Ages \\<18 or \\>60 years.\n4. BMI \\>30.\n5. Patients have history of allergy to Magnesium sulphate.\n6. Patients have uncontrolled hypertension during preoperative assessment.\n7. Patients have risk of aspiration (eg. hiatus hernia)\n8. Patients have difficult airway management during intubation with direct laryngoscope or time of intubation \\>30 seconds.\n9. Failed ventilation with LMA.\n10. Emergency surgery.'}, 'identificationModule': {'nctId': 'NCT03406403', 'briefTitle': 'A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'A Comparative Study Between Laryngeal Mask Airway and Magensium Sulphate in Attenuating Systemic Stress Response During Emergence of Patients Undergoing Supratentorial Tumours.', 'orgStudyIdInfo': {'id': 'N-102-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngeal mask airway group', 'description': '20 slips of papers will be taken and labeled as group L (LMA) These slips will be placed in an envelope and one slip will be raised for each patient.', 'interventionNames': ['Device: Laryngeal mask airway', 'Drug: Magensium sulphate', 'Other: Control group (closure of anesthetics)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magensium sulphate group', 'description': '20 slips of papers will be taken and labeled as group M (Mgso4) These slips will be placed in an envelope and one slip will be raised for each patient', 'interventionNames': ['Device: Laryngeal mask airway', 'Drug: Magensium sulphate', 'Other: Control group (closure of anesthetics)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group (closure of anesthetics)', 'description': '20 slips of papers will be taken and labeled as group C (Control) These slips will be placed in an envelope and one slip will be raised for each patient.', 'interventionNames': ['Device: Laryngeal mask airway', 'Drug: Magensium sulphate', 'Other: Control group (closure of anesthetics)']}], 'interventions': [{'name': 'Laryngeal mask airway', 'type': 'DEVICE', 'description': 'After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia', 'armGroupLabels': ['Control group (closure of anesthetics)', 'Laryngeal mask airway group', 'Magensium sulphate group']}, {'name': 'Magensium sulphate', 'type': 'DRUG', 'description': 'After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia', 'armGroupLabels': ['Control group (closure of anesthetics)', 'Laryngeal mask airway group', 'Magensium sulphate group']}, {'name': 'Control group (closure of anesthetics)', 'type': 'OTHER', 'description': 'After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia', 'armGroupLabels': ['Control group (closure of anesthetics)', 'Laryngeal mask airway group', 'Magensium sulphate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ahmed Abdalla Mohamed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Hamed Fathy, M.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Via scholar Gate'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mohamed, Ahmed A., M.D.', 'class': 'INDIV'}, {'name': 'Tarek Ahmed Radwan', 'class': 'UNKNOWN'}, {'name': 'Mohamed Farid Mohamed', 'class': 'UNKNOWN'}, {'name': 'Hamed Fathy Hamed', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University', 'investigatorFullName': 'Ahmed Abdalla', 'investigatorAffiliation': 'Cairo University'}}}}