[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645090":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":69,"collaborators":30,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":30,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":30,"overallStatus":92,"whyStopped":30,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Aswan University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: propofol",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[18],"Drug: midazolam",{"label":20,"type":10,"description":21,"interventionNames":22},"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.",[23],"Drug: Dexmedetomidine",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"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.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"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.",[20],[40],{"name":41,"affiliation":42,"role":43},"Ahmed Elsaied Aly, Ph.D.","Sohag University","STUDY_CHAIR",[45],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Mohamed Abdelhamed, M.Sc","CONTACT","+201061651065","mohamed.said@med.aswu.edu.eg",[51],{"facility":52,"status":30,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Aswan University Hospital","Asyut","Asyut Governorate","81528","Egypt","EG",{"type":59,"coordinates":60},"Point",[61,62],31.18368,27.18096,{"lat":62,"lon":61},[65],{"name":66,"role":47,"phone":67,"phoneExt":30,"email":68},"Mohamed Abdelhamed, M.Sc.","01061651065","hamedo_2020@yahoo.com",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Mohamed Abdelhameed Sayed","Assistant lecture","100645090","comparing-sedatives-for-intracranial-pressure-control-in-traumatic-brain-injury-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":84,"type":85},210,"ESTIMATED","INTERVENTIONAL",[88],"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.",[91],"Moderate-to-Severe Traumatic Brain Injury","NOT_YET_RECRUITING","2026-06-24",{"date":95,"type":96},"2026-07-01","ACTUAL",{"date":95,"type":85},{"date":99,"type":85},"2028-06-01",{"name":5,"class":6},1]