Actively Recruiting
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
Eligibility Criteria
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
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
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
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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