[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601063":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":43,"studyPopulation":33,"armGroups":44,"interventions":61,"overallOfficials":79,"centralContacts":84,"locations":93,"responsibleParty":109,"collaborators":33,"id":111,"slug":33,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":33,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":33,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":33,"overallStatus":96,"whyStopped":33,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Zagazig University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"The total intraoperative propofol consumption","The total intraoperative propofol consumption (in milligrams).","4 hours",[14,17,20,23,26,30],{"measure":15,"description":16,"timeFrame":12},"Intraoperative heart rate","Monitoring the changes in heart rate intraoperative.",{"measure":18,"description":19,"timeFrame":12},"Intraoperative mean arterial pressure","Monitoring the changes in mean arterial pressure intraoperative.",{"measure":21,"description":22,"timeFrame":12},"Brain relaxation score","Evaluating the brain relaxation right after the dura is opened using a scale from 1 to 4 (1 = perfectly relaxed, 2 = satisfactorily relaxed, 3 = firm brain, 4 = bulging brain).",{"measure":24,"description":25,"timeFrame":12},"Additional doses of intraoperative fentanyl.","The total number of patients requiring additional dose of intraoperative fentanyl.",{"measure":27,"description":28,"timeFrame":29},"The time to first request for rescue analgesia","The time to first request for rescue analgesia in first 24 hour.","The first 24 hours postoperative.",{"measure":31,"description":32,"timeFrame":29},"Postoperative pain assessment","Postoperative pain assessment by the numeric rating scale in the recovery room and at 2,4,8,16 and 24 hours after surgery.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":40},"DOUBLE",[41,42],"PARTICIPANT","OUTCOMES_ASSESSOR","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.",[45,51,56],{"label":46,"type":47,"description":48,"interventionNames":49},"Dexmedetomidine group","ACTIVE_COMPARATOR","Intravenous loading dose of dexmedetomidine 1 µg\u002Fkg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg\u002Fkg\u002Fhour.",[50],"Drug: Dexmedetomidine",{"label":52,"type":47,"description":53,"interventionNames":54},"Fentanyl group","Intravenous loading dose of fentanyl 1 µg\u002Fkg over 10 minutes before propofol infusion, followed by an intraoperative maintenance infusion of 0.5 µg\u002Fkg\u002Fhour.",[55],"Drug: Fentanyl",{"label":57,"type":47,"description":58,"interventionNames":59},"Magnesium group","Magnesium sulphate 30-50 mg\u002Fkg intravenous over 15-30 minutes before propofol infusion, followed by intraoperative maintenance infusion of 10-20 mg\u002Fkg\u002Fhour.",[60],"Drug: Magnesium",[62,69,73],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"DRUG","Dexmedetomidine","Dexmedetomidine as an adjunct to total intravenous anesthesia.",[46],[68],"Precedex",{"type":63,"name":70,"description":71,"armGroupLabels":72,"otherNames":33},"Fentanyl","Fentanyl as an adjunct to total intravenous anesthesia.",[52],{"type":63,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Magnesium","Magnesium sulphate as an adjunct to total intravenous anesthesia.",[57],[78],"Magnesium sulphate",[80],{"name":81,"affiliation":82,"role":83},"Fatma Mahmoud Ahmed, MD","Department of Anesthesia, Intensive Care & Pain Management, Zagazig University","PRINCIPAL_INVESTIGATOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":33,"email":89},"Sherif Mohammed Said Mowafy, MD","CONTACT","01003523374","sherifmowafy2012@gmail.com",{"name":91,"role":87,"phone":33,"phoneExt":33,"email":92},"Mohamed gaber, MD","mgmelsayed@medicine.zu.edu.eg",[94],{"facility":95,"status":96,"city":97,"state":33,"zip":33,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Zagazig university hospital","RECRUITING","Zagazig","Egypt","EG",{"type":101,"coordinates":102},"Point",[103,104],31.502,30.58768,{"lat":104,"lon":103},[107],{"name":108,"role":87,"phone":33,"phoneExt":33,"email":92},"Mohamed mohamed, MD",{"type":110,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100601063",false,"NCT07105618","Total Intravenous Anesthesia in Patients Undergoing Craniotomy","Comparison of Dexmedetomidine Versus Fentanyl or Magnesium Sulphate as Adjuncts to Propofol-Based Total Intravenous Anesthesia in Patients Undergoing Craniotomy","Inclusion Criteria:\n\n* Patient acceptance.\n* Physical status: American Society of Anesthesiologists Physical Status (ASA) 1\\& II.\n* Body mass index ≤ 30 kg\u002Fm2.\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.","ALL","21 Years","60 Years",{"count":121,"type":122},108,"ESTIMATED","INTERVENTIONAL",[125],"NA","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.",[128],"Anesthesia","2026-04-30",{"date":131,"type":132},"2026-05-06","ACTUAL",{"date":134,"type":132},"2025-08-10",{"date":136,"type":122},"2027-04",{"name":5,"class":6},1]