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NCT07807579
Impact of Dexmedetomidine Versus Propofol on Intracranial Pressure in Adult Traumatic Brain Injury Patients: Randomized Controlled Double-Blind Trial
Conditions: Traumatic Brain Injuries
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 80
Sponsor: Assiut University
Summary
To investigate whether dexmedetomidine or propofol is more effective in controlling intracranial pressure (ICP) (assessed via optic nerve sheath diameter "ONSD" as a primary outcome) and which is more effective in suppressing lipid peroxidation (measured via malondialdehyde "MDA" as a secondary outcome). This double-blind randomized controlled trial aims to bridge this research gap by evaluating the biochemical neuroprotective efficacy alongside the clinical outcomes of both agents in TBI patients.
Eligibility Criteria
Inclusion Criteria:
1. Patients aged between 18 and 65 years.
2. Both genders.
3. Moderate traumatic brain injury with Glasgow coma scale scores between 8 and 12 on admission, with no need for surgical operations.
4. Requiring continuous sedation for more than 24 hours.
Exclusion Criteria:
1. History of severe hepatic or renal failure.
2. Known hypersensitivity to propofol or dexmedetomidine.
3. Pre-existing severe bradycardia (heart rate less than 50 bpm) or advanced heart block.
4. Confirmed brain death or moribund patients.
5. Pregnancy or lactation.
6. Preexisting neurological disease affecting GCS interpretation.
7. General anesthesia 24 hours prior to or planned after the start of study drug infusion.
8. Serious central nervous system pathology (acute stroke, severe dementia, uncontrolled seizures).
9. Any patients with ocular trauma, orbital fractures, glaucoma, or history of optic nerve disease.
Source: ClinicalTrials.gov (NCT07807579). StuddyBuddy aggregates publicly available trial information.