Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury

Starting soon · Not applicable

Conditions studied: Moderate-to-Severe Traumatic Brain Injury

In brief

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: * Which sedative agent provides better control of intracranial pressure, assessed by optic nerve sheath diameter (ONSD), during the first 24 hours after neurosurgical intervention? * 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? 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.

Key facts

Study ID

NCT07678216

Run by

Aswan University

People needed

210

Starts

2026-07-01

Expected to finish

2028-06-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Moderate to severe traumatic brain injury with post-resuscitation Glasgow Coma Scale (GCS) ≤12
• Undergone urgent neurosurgical intervention (craniotomy, craniectomy, or ICP monitor placement) within 24 hours of injury
• Admitted to ICU and expected to require continuous sedation
• Hemodynamically stable or stabilized (defined as MAP ≥65 mmHg with vasopressor requirement ≤0.1 mcg/kg/min norepinephrine equivalent)
• Informed consent obtained from legally authorized representative

You may not qualify if…

• The Relative refusal to participate in the research.
• Known allergy or contraindication to propofol, midazolam, or dexmedetomidine
• Pre-existing neurological disorders (epilepsy, prior stroke, brain tumors, dementia) that may interfere with outcome assessment
• Severe hepatic dysfunction (Child-Pugh Class C) or acute liver failure
• Severe renal dysfunction (eGFR <30 mL/min/1.73m² or requiring renal replacement therapy)
• Pregnancy or breastfeeding
• Hemodynamic instability requiring norepinephrine >0.1 mcg/kg/min or equivalent vasopressor support
• Heart rate <50 bpm or second/third-degree AV block without pacemaker (relative contraindication for dexmedetomidine)
• Clinical determination of brain death or expected survival <24 hours
• Enrollment in another interventional trial
• Severe polytrauma requiring ongoing surgical interventions that would interfere with protocol adherence

Where it is running

• Aswan University Hospital — Asyut, Asyut Governorate, Egypt

Full record on ClinicalTrials.gov

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