drugset / Trial / NCT07678216

Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury

NCT07678216

Not yet recruiting 210 enrolled Aswan University
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-07-01
Primary completion
2028-06-01
Completion
2028-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified Intravenous
Subject Midazolam Small molecule Intravenous
Subject Propofol Small molecule Intravenous