Ketamine in Severe Traumatic Brain Injury

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06062628
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Traumatic Brain Injury
  • Traumatic Encephalopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketamine Hydrochloride — DRUG
    Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation

Study 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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine Intervention Arm
    A single dose of 0.5 mg/kg (actual body weight) of ketamine will be administered intravenously. Ketamine will be administered in addition to the patient's existing analgesia, sedation and other medicines as a part of their routine treatment.

Primary Outcome Measure

Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor) [ Time Frame: 3 hours ]

Locations (2)

FacilityCityStateZIPSite coordinators
Parkland Memorial HospitalDallasTexas75235
Anna Bashmakov, D.O.
[email protected]
214/648-4827
Parkland Memorial HospitalDallasTexas75235
Anna Bashmakov, D.O.
[email protected]
214-648-4827

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By research site
Parkland Memorial Hospital· Dallas, TX

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