Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06062628
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-09-25
Brief Title:
Ketamine in Severe Traumatic Brain Injury
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Neurophysiological Effect of Ketamine in Patients With Severe Traumatic Brain Injury
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Traumatic brain injury TBI accounts for approximately 25 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None