Ketamine for Sedation in Severe Traumatic Brain Injury (Ketamine)

This open-label randomized trial (n=50) will assess the safety of using ketamine in combination with propofol for sedation compared to the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury (TBI).

Patients meeting eligibility criteria will be randomized to either the ketamine with propofol intervention arm or the standard of care control arm. In the intervention arm, patients will receive propofol at a rate of 300 mcg/kg/hr with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr with an additional 2 mg/kg bolus of ketamine for sustained intracranial pressure elevations over 22 mmHg for greater than 5 minutes not attributed to other causes. In the control arm, patients will receive their institutional analgosedation protocol. The sedation protocols will continue until the removal of intracranial pressure monitoring.

This study is designed as a treatment-focused, randomized intervention with parallel assignment, and it’s planned to enrol 50 participants.

The primary outcome measures include the number of intracranial pressure elevations greater than 22 mmHg for greater than 5 minutes and mean intracranial pressure.

Secondary outcome measures include total time spent with intracranial pressure greater than 22 mmHg, mean cerebral perfusion pressure, total time spent with cerebral perfusion pressure less than 60 mmHg, total number of events where cerebral perfusion pressure is less than 60 mmHg for greater than 5 minutes, vasopressor dependency index, incidence of seizures, incidence of cardiac arrhythmias, mean heart rate, incidence of post-traumatic stress disorder in the outpatient setting, and Glasgow Coma Outcome Scale extended scores.

The study will be conducted by the Henry M. Jackson Foundation for the Advancement of Military Medicine in collaboration with the Uniformed Services University of the Health Sciences and Brooke Army Medical Center. It’s estimated to start in June 2024 and complete by June 2027.

Trial Details

This protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.

NCT Number NCT06429657

Data attribution

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