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NCT07678216
Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury
Conditions: Moderate-to-Severe Traumatic Brain Injury
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 210
Sponsor: Aswan University
Location: Aswan University Hospital Asyut Asyut Governorate
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 \0.1 mcg/kg/min or equivalent vasopressor support
* Heart rate \
Source: ClinicalTrials.gov (NCT07678216). StuddyBuddy aggregates publicly available trial information.