Ketamine in Severe Traumatic Brain Injury

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06062628

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
Traumatic Brain Injury Traumatic Encephalopathy	Drug: Ketamine Hydrochloride	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Outcome Measures

Primary Outcome Measures

Intracranial Pressure [3 hours]
Measurement of pressure within the rigid skill, with values greater than 22 mm Hg sustained proven to be injurious in patients with traumatic brain injury
Brain tissue oxygenation [3 hours]
Measurement of the concentration of oxygen within the brain tissue, with values less than 20 mmHg sustained proven to be injurious in patients with traumatic brain injury

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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