Clinical Trial

Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury

Study acronym: ICP-TBI
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07678216
Lead Sponsor Aswan University
Conditions Moderate-to-Severe Traumatic Brain Injury
Enrollment 210 participants
Start Date 2026-07-01
Primary Completion 2028-06-01 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-01