Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06062628

Ketamine in Severe Traumatic Brain Injury

Led by University of Texas Southwestern Medical Center · Updated on 2026-01-14

10

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ketamine in Severe Traumatic Brain Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Parkland Memorial Hospital

Dallas, Texas, United States, 75235

Actively Recruiting

2

Parkland Memorial Hospital

Dallas, Texas, United States, 75235

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Ketamine in Severe Traumatic Brain Injury | DecenTrialz