Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT07105618
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Total Intravenous Anesthesia in Patients Undergoing Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D008274', 'term': 'Magnesium'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total intraoperative propofol consumption', 'timeFrame': '4 hours', 'description': 'The total intraoperative propofol consumption (in milligrams).'}], 'secondaryOutcomes': [{'measure': 'Intraoperative heart rate', 'timeFrame': '4 hours', 'description': 'Monitoring the changes in heart rate intraoperative.'}, {'measure': 'Intraoperative mean arterial pressure', 'timeFrame': '4 hours', 'description': 'Monitoring the changes in mean arterial pressure intraoperative.'}, {'measure': 'Additional doses of intraoperative fentanyl.', 'timeFrame': '4 hours', 'description': 'The total number of patients requiring additional dose of intraoperative fentanyl.'}, {'measure': 'The time to first request for rescue analgesia', 'timeFrame': 'The first 24 hours postoperative.', 'description': 'The time to first request for rescue analgesia in first 24 hour.'}, {'measure': 'Postoperative pain assessment', 'timeFrame': 'The first 24 hours postoperative.', 'description': 'Postoperative pain assessment by the numeric rating scale in the recovery room and at 2,4,8,16 and 24 hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '20805754', 'type': 'BACKGROUND', 'citation': 'Ali AR, El Ghoneimy MN. Dexmedetomidine versus fentanyl as adjuvant to propofol: comparative study in children undergoing extracorporeal shock wave lithotripsy. Eur J Anaesthesiol. 2010 Dec;27(12):1058-64. doi: 10.1097/EJA.0b013e32833e6e2d.'}, {'pmid': '12393361', 'type': 'BACKGROUND', 'citation': 'Telci L, Esen F, Akcora D, Erden T, Canbolat AT, Akpir K. Evaluation of effects of magnesium sulphate in reducing intraoperative anaesthetic requirements. Br J Anaesth. 2002 Oct;89(4):594-8. doi: 10.1093/bja/aef238.'}, {'pmid': '39777171', 'type': 'BACKGROUND', 'citation': 'Chandar Chinnarasan V, Bidkar PU, Swaminathan S, Mani M, Vairappan B, Chatterjee P, Joy JJ, Dey A, Ramadurai R, Gunasekaran A. Comparison of dexmedetomidine versus fentanyl-based total intravenous anesthesia technique on the requirement of propofol, brain relaxation, intracranial pressure, neuronal injury, and hemodynamic parameters in patients with acute traumatic subdural hematoma undergoing emergency craniotomy: A randomized controlled trial. Surg Neurol Int. 2024 Dec 13;15:462. doi: 10.25259/SNI_892_2024. eCollection 2024.'}, {'pmid': '31664468', 'type': 'BACKGROUND', 'citation': 'Preethi J, Bidkar PU, Cherian A, Dey A, Srinivasan S, Adinarayanan S, Ramesh AS. Comparison of total intravenous anesthesia vs. inhalational anesthesia on brain relaxation, intracranial pressure, and hemodynamics in patients with acute subdural hematoma undergoing emergency craniotomy: a randomized control trial. Eur J Trauma Emerg Surg. 2021 Jun;47(3):831-837. doi: 10.1007/s00068-019-01249-4. Epub 2019 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'Craniotomy presents true anesthetic challenges, mainly due to the need to optimize cerebral perfusion, facilitate brain relaxation, achieve rapid emergence for neurologic assessment, and minimize perioperative complications.', 'detailedDescription': 'Total intravenous anesthesia, particularly with propofol-based regimens, has gained favor in neurosurgical procedures for its neuroprotective properties, and reduced intracranial pressure; however, the choice of adjunct agents in total intravenous anesthesia remains a subject of ongoing investigation, especially regarding their influence on hemodynamic stability, analgesia, brain relaxation, and postoperative outcomes.\n\nTotal intravenous anesthesia techniques for craniotomy allow rapid recovery and stable hemodynamic parameters, so they decrease the hospital stay. The current study will compare the efficacy and safety profiles of dexmedetomidine, fentanyl, and magnesium sulfate as adjuncts in total intravenous anesthesia for patients undergoing craniotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient acceptance.\n* Physical status: American Society of Anesthesiologists Physical Status (ASA) 1\\& II.\n* Body mass index ≤ 30 kg/m2.\n* Type of operation: elective craniotomy for brain tumor resection.\n* Duration of surgery: within 4 hours.\n\nExclusion Criteria:\n\n* Patient with hemodynamic instability or anticipated postoperative mechanical ventilation.\n* Patients with a known history of allergy to the study drugs.\n* Advanced hepatic, renal, cardiovascular, and neurologic diseases.\n* Patients with chronic opioid use.'}, 'identificationModule': {'nctId': 'NCT07105618', 'briefTitle': 'Total Intravenous Anesthesia in Patients Undergoing Craniotomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Comparison of Dexmedetomidine Versus Fentanyl or Magnesium Sulphate as Adjuncts to Propofol-Based Total Intravenous Anesthesia in Patients Undergoing Craniotomy', 'orgStudyIdInfo': {'id': 'Craniotomy anesthesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine group', 'description': 'Intravenous loading dose of dexmedetomidine 1 µg/kg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg/kg/hour.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl group', 'description': 'Intravenous loading dose of fentanyl 1 µg/kg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg/kg/hour.', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium group', 'description': 'Magnesium sulphate 30-50 mg/kg intravenous over 15-30 minutes before propofol infusion, followed by intraoperative maintenance infusion of 10-20 mg/kg/hour.', 'interventionNames': ['Drug: Magnesium']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Dexmedetomidine as an adjunct to total intravenous anesthesia.', 'armGroupLabels': ['Dexmedetomidine group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl as an adjunct to total intravenous anesthesia.', 'armGroupLabels': ['Fentanyl group']}, {'name': 'Magnesium', 'type': 'DRUG', 'otherNames': ['Magnesium sulphate'], 'description': 'Magnesium sulphate as an adjunct to total intravenous anesthesia.', 'armGroupLabels': ['Magnesium group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed mohamed, MD', 'role': 'CONTACT', 'email': 'mgmelsayed@medicine.zu.edu.eg'}], 'facility': 'Zagazig university hospital', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'Sherif Mohammed Said Mowafy, MD', 'role': 'CONTACT', 'email': 'sherifmowafy2012@gmail.com', 'phone': '01003523374'}, {'name': 'Mohamed gaber, MD', 'role': 'CONTACT', 'email': 'mgmelsayed@medicine.zu.edu.eg'}], 'overallOfficials': [{'name': 'Fatma Mahmoud Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia, Intensive Care & Pain Management, Zagazig University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}