Ketamine in Severe Traumatic Brain Injury

This study is looking at how Ketamine Hydrochloride affects people with severe traumatic brain injury (TBI). Researchers want to see if giving Ketamine Hydrochloride can help manage important measurements in the brain, specifically intracranial pressure (ICP, pressure inside the skull) and brain tissue oxygenation (how much oxygen is in the brain tissue). To join, you must be at least 18 years old and have severe TBI with monitors already in place to measure ICP and brain tissue oxygenation. The study will measure these brain parameters 3 hours after receiving Ketamine Hydrochloride. This study is currently unclear on its recruitment status and plans to enroll 10 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 10 participants.
What's involved
Participants will receive Ketamine Hydrochloride, and their intracranial pressure and brain tissue oxygenation will be measured.
Compensation
Not stated in the trial record.
Follow-up
Measurements of intracranial pressure and brain tissue oxygenation will be taken at 3 hours after intervention.

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NCT06062628

Ketamine in Severe Traumatic Brain Injury

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~10 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:Ketamine Hydrochloride

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor)
Measured over 3 hours
+1 more outcome measured
Traumatic Brain Injury
Traumatic Encephalopathy
2 sites across 1 states
Texas2
  • Anna Bashmakov, D.O. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

Severe traumatic brain injury
Placement of intracranial monitor for measurement of intracranial pressure and brain tissue oxygenation
Age greater than or equal to 18 years

Exclusion

Documented allergy to ketamine
Sinus tachycardia with sustained heart rate \>120
Any episode of non-sinus tachycardia
Documented history of schizophrenia
Systolic blood pressure \> 180, diastolic blood pressure \> 120
Documented episode(s) of ICP elevations \>25 mm Hg sustained greater than 5 minutes within 24 hours
Similar episodes as above of PbtO2 \<15 mmHg
Positive pregnancy test and/or is currently breast-feeding
  • Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor)3 hours

    Measurement of pressure within the rigid skill, with values greater than 22 mm Hg sustained proven to be injurious in patients with traumatic brain injury

  • Brain tissue oxygenation (measured by intracranial oxygen probe)3 hours

    Measurement of the concentration of oxygen within the brain tissue, with values less than 20 mmHg sustained proven to be injurious in patients with traumatic brain injury