Ketamine in Severe Traumatic Brain Injury

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.

Trial Details

Traumatic brain injury (TBI) accounts for approximately 2.5 million visits to emergency departments in the United States each year. After decades of research, management strategies for severe TBI (sTBI) patients are still evolving. Optimizing intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are paramount in the management of these patients and placement of these monitors is the current standard-of-care. However, monitoring brain oxygenation (PbtO2) with invasive intraparenchymal monitors is currently under investigation in the management of severe TBI and placement of these monitors is gaining widespread use. This has opened the door for the use of tiered therapy to optimize ICP and PbtO2 simultaneously. Current evidence indicates that correction of ICP, CPP and PbtO2 in sTBI requires optimized analgesia and sedation. Ketamine is one of the few drugs available that has both sedative and analgesic properties and does not commonly compromise respiratory drive like opioids and sedative-hypnotics. However, traditionally, ketamine has been viewed as contraindicated in the setting of TBI due to concerns for elevation in ICP. Yet, new data has cast this long-held assumption into significant doubt. Hence the present pilot study will characterize the neurophysiological response to a single dose of ketamine in critically-ill TBI patient with ICP and PbtO2 monitoring.

NCT Number NCT06062628

Data attribution

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