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NCT06062628 | RECRUITING | Traumatic Brain Injury

Ketamine in Severe Traumatic Brain Injury
Sponsor:

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

Anna Bashmakov

Brief 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.

Condition or disease

Traumatic Brain Injury

Traumatic Encephalopathy

Intervention/treatment

Ketamine Hydrochloride

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury
Actual Study Start Date : 2025-12-01
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2026-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Ketamine in Severe Traumatic Brain Injury

Location Details

NCT06062628

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How to Participate

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Locations

RECRUITING

United States, Texas

Parkland Memorial Hospital

dallas, Texas, United States, 75235

RECRUITING

United States, Texas

Parkland Memorial Hospital

dallas, Texas, United States, 75235