Ketamine in Severe Traumatic Brain Injury

Last updated: August 26, 2024
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Memory Loss

Traumatic Brain Injury

Neurologic Disorders

Treatment

Ketamine Hydrochloride

Clinical Study ID

NCT06062628
STU-2023-0805
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Severe traumatic brain injury

  • Placement of intracranial monitor for measurement of intracranial pressure and braintissue oxygenation

  • Age greater than or equal to 18 years

Exclusion

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 minuteswithin 24 hours

  • Similar episodes as above of PbtO2 <15 mmHg

  • Positive pregnancy test and/or is currently breast-feeding

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Ketamine Hydrochloride
Phase: 1
Study Start date:
March 18, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Parkland Memorial Hospital

    Dallas, Texas 75235
    United States

    Active - Recruiting

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