An interventional study of propofol and midazolam in Moderate-to-Severe Traumatic Brain Injury, sponsored by Aswan University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Aswan University · Not applicable, Interventional, and Treatment
Among 42 studies in Brain Injuries, Traumatic with a site in Egypt — 14 open to participants now, 18 under way, 3 of them phase 3. Brain Injuries, Traumatic · Egypt.
Among the 42 studies in Brain Injuries, Traumatic with a site in Egypt, this one has the largest planned enrollment of the 29 interventional ones that give a count, is one of 8 that started in 2026, is one of 13 with no phase, reaches primary completion later than 16 of the 17 other live ones, and was the 35th registered.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
Browse Brain Injuries, Traumatic studies →14 of the 42 studies in Brain Injuries, Traumatic with a site in Egypt are open now. Recruiting first, the newest first:
Tanta University · Sites in Egypt
Sohag University · Sites in Egypt
Mansoura University · Sites in Egypt
Mansoura University · Sites in Egypt
Mansoura University · Sites in Egypt
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 4 · Phase 3 7 · Phase 4 3
First in 2016; this study’s year is marked. 8 started in 2026.
This study's planned enrollment of 210 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Median enrollment 80 across the 29 interventional studies, 60 across the 13 observational. Of the 16 that completed or were terminated, 1 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 42 has an industry lead sponsor. The 10 most frequent:
Aswan University is the lead sponsor of 47 studies on the registry; 21 are open to participants now.
Aswan University has 1 study filed under Brain Injuries, Traumatic — fewer than ten, so there is no comparison to draw.
4 of the studies in Brain Injuries, Traumatic with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07816588Ain Shams UniversityTCD and ONSD for Noninvasive Assessment of Increased ICP in TBI | 2026-12-07 |
| NCT07696598Sohag UniversityExtradural Hematoma in Pediatrics After Acute Head Injury: Surgical and Clinical Outcome | 2027-01-01 |
| NCT07883083Minia UniversityClosed Versus Open Endotracheal Suctioning and Ventilator-Associated Pneumonia in Severe Traumatic Brain Injury | 2027-04-30 |
| NCT07722702Benha UniversityONSD Trajectory in Rebound ICH | 2027-09-01 |
Among the 42 studies in Brain Injuries, Traumatic with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
The main questions it aims to answer are:
Participants 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.
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.
Propofol, 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.
This 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.
Participants 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.
The 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥18 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive continuous intravenous propofol infusion initiated at 1 mg/kg/h and titrated to 1-4 mg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours.
Drug: propofol
Participants receive continuous intravenous midazolam infusion initiated at 0.03 mg/kg/h and titrated to 0.02-0.1 mg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours.
Drug: midazolam
Participants receive continuous intravenous dexmedetomidine infusion initiated at 0.4 μg/kg/h and titrated to 0.2-0.7 μg/kg/h to maintain a target RASS score of -3 to -4 for 24 hours.
Drug: Dexmedetomidine
Continuous intravenous propofol infusion initiated at 1 mg/kg/h and titrated within a range of 1-4 mg/kg/h to maintain a target Richmond Agitation-Sedation Scale (RASS) score of -3 to -4 during the 24-hour study intervention period.
Continuous intravenous midazolam infusion initiated at 0.03 mg/kg/h and titrated within a range of 0.02-0.1 mg/kg/h 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/kg may be administered if rapid sedation is required.
Continuous intravenous dexmedetomidine infusion initiated at 0.4 μg/kg/h and titrated within a range of 0.2-0.7 μg/kg/h 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.
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.
Time frame: Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation
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.
Time frame: 24 hours after initiation of sedation
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.
Time frame: 24 hours after initiation of sedation
Need for Rescue Sedation
Proportion of patients requiring rescue sedation due to failure to achieve target sedation despite maximum protocol dose.
Time frame: 24 hours after initiation of sedation
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)
Time frame: 24 hours after initiation of sedation
Incidence of Hypotension
Incidence of hypotension, defined as mean arterial pressure (MAP) \<65 mmHg or cerebral perfusion pressure (CPP) \<60 mmHg.
Time frame: 24 hours after initiation of study sedation
Vasopressor Requirements
Vasopressor requirements assessed by the proportion of patients requiring vasopressor support.
Time frame: 24 hours after initiation of study sedation.
Incidence of Bradycardia.
Percentage of participants who develop bradycardia, defined as a sustained heart rate \<50 beats per minute (bpm).
Time frame: 24 hours after initiation of study sedation.
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.
Time frame: Baseline and 24 hours after initiation of study sedation.
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.
Time frame: From initiation of mechanical ventilation until successful extubation, assessed for up to 30 days.
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.
Time frame: From discontinuation of study sedation until achievement of a Glasgow Coma Scale motor score of ≥5, assessed for up to 30 days.
ICU Mortality
Death from any cause during the ICU stay following urgent neurosurgical intervention for traumatic brain injury.
Time frame: From ICU admission until ICU discharge, assessed for up to 30 days.
Plan to share: No — Individual participant data (IPD) will not be shared because the study contains sensitive clinical data, and sharing could compromise participant confidentiality. Data are subject to institutional policies and ethics committee restrictions.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jun 2028, 23 months later.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 23 months is below that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Propofol · Midazolam · Dexmedetomidine
Aswan University