Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-17 @ 9:00 PM
Study NCT ID:
NCT06516861
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2024-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'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': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-08', 'size': 2083113, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-17T11:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'masks the subjects and care provider from knowing which study treatment'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The design of this study used a double-blind randomized controlled clinical trial with pre test post test with control group design, to assess the comparison of hemodynamics and post-intubation cortisol in the administration of intravenous Magnesium sulfate and intravenous Lidocaine. The study sample was all patients who underwent surgery who met the inclusion and exclusion criteria.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-06-23', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': '1 month', 'description': 'mmHg'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': '1 month', 'description': 'mmHg'}, {'measure': 'Mean Arterial Pressure (MAP)', 'timeFrame': '1 month', 'description': 'Estimated by using a formula in which the lower (diastolic) blood pressure is doubled and added to the higher (systolic) blood pressure and that composite sum then is divided by 3 to estimate MAP'}, {'measure': 'Heart Rate', 'timeFrame': '1 month', 'description': 'beats per minute'}], 'secondaryOutcomes': [{'measure': 'Cortisol Levels', 'timeFrame': '1 month', 'description': 'Cortisol Levels in nmol/L'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Craniotomy', 'Intubation', 'Lidocaine', 'MgSO4'], 'conditions': ['Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '24879167', 'type': 'RESULT', 'citation': 'Bousselmi R, Lebbi MA, Bargaoui A, Ben Romdhane M, Messaoudi A, Ben Gabsia A, Ferjani M. Lidocaine reduces endotracheal tube associated side effects when instilled over the glottis but not when used to inflate the cuff: A double blind, placebo-controlled, randomized trial. Tunis Med. 2014 Jan;92(1):29-33.'}, {'pmid': '32174664', 'type': 'RESULT', 'citation': 'Silpa AR, Koshy KA, Subramanian A, Pradeep KK. Comparison of the efficacy of two doses of dexmedetomidine in attenuating the hemodynamic response to intubation in patients undergoing elective cardiac surgery: A randomized double-blinded study. J Anaesthesiol Clin Pharmacol. 2020 Jan-Mar;36(1):83-87. doi: 10.4103/joacp.JOACP_235_18. Epub 2020 Feb 18.'}, {'pmid': '33109859', 'type': 'RESULT', 'citation': 'Sriganesh K, Syeda S, Shanthanna H, Venkataramaiah S, Palaniswamy SR. Effect of Opioid Versus Non-Opioid Analgesia on Surgical Pleth Index and Biomarkers of Surgical Stress During Neurosurgery for Brain Tumors: Preliminary Findings. Neurol India. 2020 Sep-Oct;68(5):1101-1105. doi: 10.4103/0028-3886.294559.'}, {'pmid': '24009246', 'type': 'RESULT', 'citation': 'Finnerty CC, Mabvuure NT, Ali A, Kozar RA, Herndon DN. The surgically induced stress response. JPEN J Parenter Enteral Nutr. 2013 Sep;37(5 Suppl):21S-9S. doi: 10.1177/0148607113496117.'}, {'type': 'RESULT', 'citation': 'Rastogi, S., Yadav, S. K., Agarwal, A., Kumar, S., & Malviya, D. (2020). Biochemical markers and haemodynamic changes of stress response after intubation with direct laryngoscopy versus video laryngoscopy versus fiberoptic intubation: A comparative study. Indian Journal of Clinical Anaesthesia, 7(4), 681-686.'}, {'pmid': '30047158', 'type': 'RESULT', 'citation': 'Prete A, Yan Q, Al-Tarrah K, Akturk HK, Prokop LJ, Alahdab F, Foster MA, Lord JM, Karavitaki N, Wass JA, Murad MH, Arlt W, Bancos I. The cortisol stress response induced by surgery: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2018 Nov;89(5):554-567. doi: 10.1111/cen.13820. Epub 2018 Aug 23.'}, {'pmid': '19250287', 'type': 'RESULT', 'citation': 'Gil-Gouveia R, Goadsby PJ. Neuropsychiatric side-effects of lidocaine: examples from the treatment of headache and a review. Cephalalgia. 2009 May;29(5):496-508. doi: 10.1111/j.1468-2982.2008.01800.x. Epub 2009 Feb 24.'}, {'pmid': '34061894', 'type': 'RESULT', 'citation': 'Misganaw A, Sitote M, Jemal S, Melese E, Hune M, Seyoum F, Sema A, Bimrew D. Comparison of intravenous magnesium sulphate and lidocaine for attenuation of cardiovascular response to laryngoscopy and endotracheal intubation in elective surgical patients at Zewditu Memorial Hospital Addis Ababa, Ethiopia. PLoS One. 2021 Jun 1;16(6):e0252465. doi: 10.1371/journal.pone.0252465. eCollection 2021.'}, {'pmid': '28017170', 'type': 'RESULT', 'citation': 'Mendonca FT, de Queiroz LM, Guimaraes CC, Xavier AC. Effects of lidocaine and magnesium sulfate in attenuating hemodynamic response to tracheal intubation: single-center, prospective, double-blind, randomized study. Braz J Anesthesiol. 2017 Jan-Feb;67(1):50-56. doi: 10.1016/j.bjane.2015.08.004. Epub 2016 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'The sample was randomly divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. These groups will be checked for hemodynamic changes and cortisol values.', 'detailedDescription': 'The sample was randomly divided into 3 groups and divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. The first group of patients was given Magnesium Sulfate 30 mg /kg diluted in 20 ml with NaCl 0.9%, labeled with code A, and given in 5 minutes with a syringe pump, The second group was given Lidocaine 1.5 mg/kg diluted in 20 ml with NaCl 0.9%, labeled with code B and given in 5 minutes with a syringe pump, The third group was given NaCl 0.9%, in a 20 ml syringe labeled with code C and given in 5 minutes with a syringe pump. After induction and intubation, patients were then recorded systolic blood pressure, diastolic blood pressure, MAP, and pulse at T1 (3 minutes), T2 (5 minutes), T3 (7 minutes), and T4 (10 minutes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18-65 years;\n* body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2;\n* patients or their families agreed to be used as research subjects;\n* elective non-traumatic craniotomy cases, namely supratentorial brain tumor evacuation, intracerebral hemorrhage evacuation, subdural hemorrhage, cerebrovascular correction.\n\nExclusion Criteria:\n\n* cardiac, hepatic, and renal disorders;\n* patients with pregnancy;\n* hypertension or hypotension before surgery;\n* hypersensitivity to Magnesium Sulfate and/or Lidocaine;\n* patients with chronic use of corticosteroid drugs, calcium channel blockers, magnesium-containing drugs, and opioids;\n* risk of difficult intubation and ventilation according to the LEMON score and MOANS score criteria;\n* impaired cortisol secretion (pituitary tumor or hypothalamic tumor or adrenal gland disorder); and\n* patients with hypocortisol or hypercortisol at T0 serum cortisol examination.'}, 'identificationModule': {'nctId': 'NCT06516861', 'briefTitle': 'Magnesium Sulphate and Lidocaine in Hemodynamic Changes and Cortisol Levels', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sumatera Utara'}, 'officialTitle': 'Comparison of Magnesium Sulphate 30 mg/Kg With Lidocaine 1,5 mg/Kg in Hemodynamic Changes and Cortisol Level Post-intubation in Patient Undergoing Craniotomy', 'orgStudyIdInfo': {'id': 'USumateraUtara01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MgSO4 intravenous', 'description': 'Sample will be given MgSO4 30mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery', 'interventionNames': ['Drug: Magnesium Sulfate 20 MG/ML']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine intravenous', 'description': 'Sample will be given Lidocain 1.5mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery', 'interventionNames': ['Drug: Lidocaine IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl 0,9% Intravenous', 'description': 'Sample will be given NaCl 0,9% Intravenous 20 ml as a premedication drugs before intubation for all patients who had craniotomy surgery', 'interventionNames': ['Drug: saline solution']}], 'interventions': [{'name': 'Magnesium Sulfate 20 MG/ML', 'type': 'DRUG', 'otherNames': ['Magnesium sulfate injection'], 'description': 'Administered intravenously with a dose of 30 mg/kg', 'armGroupLabels': ['MgSO4 intravenous']}, {'name': 'Lidocaine IV', 'type': 'DRUG', 'otherNames': ['Lidocaine'], 'description': 'Administered intravenously with a dose of 1.5mg/Kg', 'armGroupLabels': ['Lidocaine intravenous']}, {'name': 'saline solution', 'type': 'DRUG', 'otherNames': ['NaCl 0,9% Solution'], 'description': 'Administered intravenously with 20 ml', 'armGroupLabels': ['NaCl 0,9% Intravenous']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20136', 'city': 'Medan', 'state': 'North Sumatra', 'country': 'Indonesia', 'facility': 'Adam Malik General Hospital', 'geoPoint': {'lat': 3.58333, 'lon': 98.66667}}], 'overallOfficials': [{'name': 'Rr Sinta Irina, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitas Sumatera Utara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arsil Radiansyah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitas Sumatera Utara', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor', 'investigatorFullName': 'Arsil Radiansyah', 'investigatorAffiliation': 'Universitas Sumatera Utara'}}}}