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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Intervention Arm | Experimental | A single dose of 0.5 mg/kg (actual body weight) of ketamine will be administered intravenously. Ketamine will be administered in addition to the patient's existing analgesia, sedation and other medicines as a part of their routine treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hydrochloride | Drug | Administration of ketamine with subsequent measurement of intracranial pressure and brain tissue oxygenation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Pressure (ICP, measured by external ventricular drain and/or ICP monitor) | 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 | 3 hours |
| Brain tissue oxygenation (measured by intracranial oxygen probe) | 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 | 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Bashmakov, D.O. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Memorial Hospital | Recruiting | Dallas | Texas | 75235 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Parkland Memorial Hospital | Recruiting | Dallas | Texas | 75235 | United States |
|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |