[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645090":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":65,"studyPopulation":54,"armGroups":66,"interventions":83,"overallOfficials":97,"centralContacts":102,"locations":108,"responsibleParty":127,"collaborators":54,"id":131,"slug":54,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":54,"enrollmentInfo":140,"targetDuration":54,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":54,"overallStatus":149,"whyStopped":54,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Aswan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Intracranial Pressure Control Assessed by Optic Nerve Sheath Diameter (ONSD)","Intracranial pressure control will be evaluated using serial optic nerve sheath diameter (ONSD) measurements obtained by ocular ultrasonography. The primary outcome will be the mean ONSD over the 24-hour intervention period, analyzed as a continuous measure of intracranial pressure control.","Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation",[14,18,21,24,27,31,35,38,42,46,50],{"measure":15,"description":16,"timeFrame":17},"Proportion of Time at Target Sedation Level","Percentage of assessment time during which patients maintained the target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. The Richmond Agitation-Sedation Scale ranges from +4 (combative) to -5 (unarousable). Higher scores indicate greater agitation, whereas lower scores indicate deeper sedation. The target sedation level for this study is RASS -3 to -4.","24 hours after initiation of sedation",{"measure":19,"description":20,"timeFrame":17},"Mean Richmond Agitation-Sedation Scale (RASS) Score","Mean Richmond Agitation-Sedation Scale (RASS) score during the 24-hour intervention period. The RASS ranges from +4 (combative) to -5 (unarousable), with target sedation defined as -3 to -4.",{"measure":22,"description":23,"timeFrame":17},"Need for Rescue Sedation","Proportion of patients requiring rescue sedation due to failure to achieve target sedation despite maximum protocol dose.",{"measure":25,"description":26,"timeFrame":17},"Time to Achieve Target Sedation","Time from initiation of study sedative infusion until achievement of target Richmond Agitation-Sedation Scale (RASS) score (-3 to -4).The RASS ranges from +4 (combative) to -5 (unarousable)",{"measure":28,"description":29,"timeFrame":30},"Incidence of Hypotension","Incidence of hypotension, defined as mean arterial pressure (MAP) \\\u003C65 mmHg or cerebral perfusion pressure (CPP) \\\u003C60 mmHg.","24 hours after initiation of study sedation",{"measure":32,"description":33,"timeFrame":34},"Vasopressor Requirements","Vasopressor requirements assessed by the proportion of patients requiring vasopressor support.","24 hours after initiation of study sedation.",{"measure":36,"description":37,"timeFrame":34},"Incidence of Bradycardia.","Percentage of participants who develop bradycardia, defined as a sustained heart rate \\\u003C50 beats per minute (bpm).",{"measure":39,"description":40,"timeFrame":41},"Percentage of Participants Who Developed Secondary Brain Injury ✅","Secondary brain injury will be assessed by the presence of new or progressive findings on brain computed tomography (CT) compared with baseline imaging, including new intracranial hemorrhage, progression of cerebral edema (defined as \\>25% increase in midline shift or worsening basal cistern effacement), new cerebral infarction, or transtentorial or uncal herniation. Brain CT scans will be reviewed by a blinded neuroradiologist.","Baseline and 24 hours after initiation of study sedation.",{"measure":43,"description":44,"timeFrame":45},"Duration of Mechanical Ventilation","Duration of invasive mechanical ventilation, measured as the number of days from initiation of mechanical ventilation until successful liberation from ventilatory support.","From initiation of mechanical ventilation until successful extubation, assessed for up to 30 days.",{"measure":47,"description":48,"timeFrame":49},"Time to Neurological Awakening","Time from discontinuation of study sedation to achievement of a Glasgow Coma Scale (GCS) motor score of ≥5. The Glasgow Coma Scale motor component ranges from 1 (no motor response) to 6 (obeys commands), with higher scores indicating better neurological function.","From discontinuation of study sedation until achievement of a Glasgow Coma Scale motor score of ≥5, assessed for up to 30 days.",{"measure":51,"description":52,"timeFrame":53},"ICU Mortality","Death from any cause during the ICU stay following urgent neurosurgical intervention for traumatic brain injury.","From ICU admission until ICU discharge, assessed for up to 30 days.",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":54,"timePerspective":54,"maskingInfo":60},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel treatment groups receiving continuous sedation for 24 hours following urgent neurosurgical intervention for moderate-to-severe traumatic brain injury.\n\nGroup A will receive propofol initiated at 1 mg\u002Fkg\u002Fh and titrated within a range of 1-4 mg\u002Fkg\u002Fh to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4.\n\nGroup B will receive midazolam initiated at 0.03 mg\u002Fkg\u002Fh and titrated within a range of 0.02-0.1 mg\u002Fkg\u002Fh to maintain the target RASS score. An initial bolus dose of 0.05 mg\u002Fkg may be administered if rapid sedation is required.\n\nGroup C will receive dexmedetomidine initiated at 0.4 μg\u002Fkg\u002Fh and titrated within a range of 0.2-0.7 μg\u002Fkg\u002Fh to maintain the target RASS score.\n\nParticipants will remain in their assigned treatment group throughout the intervention period, and outcomes will be compared between groups. The trial uses a prospective randomized parallel-group design with blinded","TREATMENT",{"masking":61,"maskingDescription":62,"whoMasked":63},"SINGLE","This is an open-label randomized trial. Treating clinicians and investigators are aware of treatment allocation. Outcome assessment is blinded; optic nerve sheath diameter (ONSD) measurements are performed by a blinded ultrasonographer, and radiological outcomes are evaluated by a blinded neuroradiologist who is unaware of treatment assignment.",[64],"OUTCOMES_ASSESSOR","Traumatic brain injury (TBI) is a major cause of mortality and long-term disability worldwide. Prevention of secondary brain injury through optimal control of intracranial pressure (ICP) is a key component of intensive care management in patients with moderate-to-severe TBI. Sedative agents are routinely used to facilitate mechanical ventilation, reduce cerebral metabolic demand, and improve ICP control. However, uncertainty remains regarding the optimal sedative agent for this patient population.\n\nPropofol, midazolam, and dexmedetomidine are among the most commonly used sedatives in neurocritical care. Each agent has distinct pharmacological characteristics that may influence intracranial pressure, hemodynamic stability, neurological assessment, and clinical outcomes. Despite widespread use, direct comparative evidence between these agents remains limited.\n\nThis prospective randomized clinical trial aims to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adult patients with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention. Intracranial pressure will be assessed noninvasively using serial optic nerve sheath diameter (ONSD) measurements obtained by ocular ultrasonography during the first 24 hours of continuous sedation.\n\nParticipants will be randomly assigned to receive one of the three sedative regimens according to a standardized protocol targeting a Richmond Agitation-Sedation Scale (RASS) score of -3 to -4. Standard neurocritical care management and analgesia protocols will be applied to all study groups.\n\nThe study will evaluate the comparative effects of the three sedative agents on intracranial pressure control, sedation quality, hemodynamic stability, adverse events, secondary brain injury, and short-term clinical outcomes. The findings are expected to provide evidence to guide sedative selection in patients with moderate-to-severe traumatic brain injury, particularly in settings where invasive intracranial pressure monitoring is not routinely available.",[67,73,78],{"label":68,"type":69,"description":70,"interventionNames":71},"Propofol","EXPERIMENTAL","Participants receive continuous intravenous propofol infusion initiated at 1 mg\u002Fkg\u002Fh and titrated to 1-4 mg\u002Fkg\u002Fh to maintain a target RASS score of -3 to -4 for 24 hours.",[72],"Drug: propofol",{"label":74,"type":69,"description":75,"interventionNames":76},"Midazolam","Participants receive continuous intravenous midazolam infusion initiated at 0.03 mg\u002Fkg\u002Fh and titrated to 0.02-0.1 mg\u002Fkg\u002Fh to maintain a target RASS score of -3 to -4 for 24 hours.",[77],"Drug: midazolam",{"label":79,"type":69,"description":80,"interventionNames":81},"dexmedetomidine","Participants receive continuous intravenous dexmedetomidine infusion initiated at 0.4 μg\u002Fkg\u002Fh and titrated to 0.2-0.7 μg\u002Fkg\u002Fh to maintain a target RASS score of -3 to -4 for 24 hours.",[82],"Drug: Dexmedetomidine",[84,89,93],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":54},"DRUG","propofol","Continuous intravenous propofol infusion initiated at 1 mg\u002Fkg\u002Fh and titrated within a range of 1-4 mg\u002Fkg\u002Fh to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period.",[68],{"type":85,"name":90,"description":91,"armGroupLabels":92,"otherNames":54},"midazolam","Continuous intravenous midazolam infusion initiated at 0.03 mg\u002Fkg\u002Fh and titrated within a range of 0.02-0.1 mg\u002Fkg\u002Fh to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. An initial bolus dose of 0.05 mg\u002Fkg may be administered if rapid sedation is required.",[74],{"type":85,"name":94,"description":95,"armGroupLabels":96,"otherNames":54},"Dexmedetomidine","Continuous intravenous dexmedetomidine infusion initiated at 0.4 μg\u002Fkg\u002Fh and titrated within a range of 0.2-0.7 μg\u002Fkg\u002Fh to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period. No loading dose will be administered.",[79],[98],{"name":99,"affiliation":100,"role":101},"Ahmed Elsaied Aly, Ph.D.","Sohag University","STUDY_CHAIR",[103],{"name":104,"role":105,"phone":106,"phoneExt":54,"email":107},"Mohamed Abdelhamed, M.Sc","CONTACT","+201061651065","mohamed.said@med.aswu.edu.eg",[109],{"facility":110,"status":54,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"Aswan University Hospital","Asyut","Asyut Governorate","81528","Egypt","EG",{"type":117,"coordinates":118},"Point",[119,120],31.18368,27.18096,{"lat":120,"lon":119},[123],{"name":124,"role":105,"phone":125,"phoneExt":54,"email":126},"Mohamed Abdelhamed, M.Sc.","01061651065","hamedo_2020@yahoo.com",{"type":128,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"PRINCIPAL_INVESTIGATOR","Mohamed Abdelhameed Sayed","Assistant lecture","100645090",false,"NCT07678216","Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury","Effect of Propofol, Midazolam, and Dexmedetomidine on Intracranial Pressure and Clinical Outcomes in Patients With Moderate-to-Severe Traumatic Brain Injury Undergoing Urgent Neurosurgical Intervention","ICP-TBI","Inclusion Criteria:\n\n* Age ≥18 years\n\n  * Moderate to severe traumatic brain injury with post-resuscitation Glasgow Coma Scale (GCS) ≤12\n  * Undergone urgent neurosurgical intervention (craniotomy, craniectomy, or ICP monitor placement) within 24 hours of injury\n  * Admitted to ICU and expected to require continuous sedation\n  * Hemodynamically stable or stabilized (defined as MAP ≥65 mmHg with vasopressor requirement ≤0.1 mcg\u002Fkg\u002Fmin norepinephrine equivalent)\n  * Informed consent obtained from legally authorized representative\n\nExclusion Criteria:\n\n* The Relative refusal to participate in the research.\n* Known allergy or contraindication to propofol, midazolam, or dexmedetomidine\n* Pre-existing neurological disorders (epilepsy, prior stroke, brain tumors, dementia) that may interfere with outcome assessment\n* Severe hepatic dysfunction (Child-Pugh Class C) or acute liver failure\n* Severe renal dysfunction (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² or requiring renal replacement therapy)\n* Pregnancy or breastfeeding\n* Hemodynamic instability requiring norepinephrine \\>0.1 mcg\u002Fkg\u002Fmin or equivalent vasopressor support\n* Heart rate \\\u003C50 bpm or second\u002Fthird-degree AV block without pacemaker (relative contraindication for dexmedetomidine)\n* Clinical determination of brain death or expected survival \\\u003C24 hours\n* Enrollment in another interventional trial\n* Severe polytrauma requiring ongoing surgical interventions that would interfere with protocol adherence","ALL","18 Years",{"count":141,"type":142},210,"ESTIMATED","INTERVENTIONAL",[145],"NA","The goal of this clinical trial is to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adults with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention.\n\nThe main questions it aims to answer are:\n\n* Which sedative agent provides better control of intracranial pressure, assessed by optic nerve sheath diameter (ONSD), during the first 24 hours after neurosurgical intervention?\n* How do the three sedative agents compare in achieving target sedation depth, maintaining hemodynamic stability, and improving short-term clinical outcomes such as ICU mortality, duration of mechanical ventilation, and ICU length of stay?\n\nParticipants will be randomly assigned to receive propofol, midazolam, or dexmedetomidine for 24 hours of continuous sedation. Clinical, hemodynamic, and neurological outcomes will be assessed and compared among the three study groups.",[148],"Moderate-to-Severe Traumatic Brain Injury","NOT_YET_RECRUITING","2026-06-24",{"date":152,"type":153},"2026-07-01","ACTUAL",{"date":152,"type":142},{"date":156,"type":142},"2028-06-01",{"name":5,"class":6},1]