Using ketamine to treat severe traumatic brain injury
Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury
EARLY_PHASE1 · University of Texas Southwestern Medical Center · NCT06062628
This study is testing if ketamine can help improve treatment for people with severe traumatic brain injuries by managing their pain and brain pressure better.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT06062628 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of ketamine hydrochloride in patients with severe traumatic brain injury (sTBI) who require monitoring of intracranial pressure and brain tissue oxygenation. The study aims to optimize both intracranial pressure and cerebral perfusion pressure while ensuring adequate analgesia and sedation. By utilizing ketamine, which has sedative and analgesic properties without significantly affecting respiratory drive, the trial seeks to improve management strategies for sTBI patients. The approach is based on the need for tiered therapy to address multiple critical parameters in the care of these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe traumatic brain injury requiring intracranial monitoring.
Not a fit: Patients with documented allergies to ketamine or those with specific cardiovascular or neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance recovery outcomes for patients with severe traumatic brain injury.
How similar studies have performed: While the use of ketamine in this context is innovative, similar studies have shown promise in optimizing management strategies for traumatic brain injury.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Dallas, Texas and 1 other locations
- Parkland Memorial Hospital — Dallas, Texas, United States (RECRUITING)
- Parkland Memorial Hospital — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Anna Bashmakov, D.O. — University of Texas Southwestern Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury, Traumatic Encephalopathy, ketamine, traumatic brain injury