Ketamine in Severe Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketamine Hydrochloride.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury, Traumatic Encephalopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury
Overview
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.
Interventions
- Drug Ketamine Hydrochloride
Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation
Primary outcome measures
- Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor) [Time frame: 3 hours]
- Brain tissue oxygenation (measured by intracranial oxygen probe) [Time frame: 3 hours]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Parkland Memorial Hospital — Dallas
- Parkland Memorial Hospital — Dallas
Identifiers
NCT: NCT06062628 · STU-2023-0805