Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAswan University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • propofol
  • midazolam
  • Dexmedetomidine

Treatment groups

210 Participants
are divided into 3 treatment groups

Sponsors and collaborators