This early Phase I interventional trial (n=10) will assess the neurophysiological effect of ketamine in patients with severe Traumatic Brain Injury (TBI).
Traditionally, ketamine has been considered contraindicated due to concerns about elevated intracranial pressure (ICP), but new data challenges this assumption. This study aims to characterise the response to a single dose of ketamine in critically ill TBI patients with ICP and brain tissue oxygenation (PbtO2) monitoring. The primary outcome measures will include intracranial pressure and brain tissue oxygenation levels, measured within 3 hours post-administration.
Participants must be aged 18 or above and have severe TBI with intracranial monitors in place. Exclusion criteria include documented allergy to ketamine, certain cardiac conditions, and elevated ICP or low PbtO2 levels.
The study, sponsored by the University of Texas Southwestern Medical Center, is expected to start in February 2024 and complete by November 2024.
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University of TexasThe University of Texas is conducting research with psychedelics across locations in Houston, Austin, Dallas and San Antonio.