Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-04-16
Brief Title:
Ketamine for Sedation in Severe Traumatic Brain Injury
Sponsor:
Henry M Jackson Foundation for the Advancement of Military Medicine
Organization:
Henry M Jackson Foundation for the Advancement of Military Medicine
Study Overview
Official Title:
Ketamine for Sedation in Severe Traumatic Brain Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Ketamine
Brief Summary:
This protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury
Detailed Description:
Patients meeting eligibility criteria and consent having been obtained by LAR will undergo randomization to either the ketamine with propofol intervention arm or the standard of care control arm
Patients enrolled in the intervention arm will receive propofol at a rate of 300 mcgkghr 5 mcgkgmin with the addition of ketamine at a rate of 1000-5000 mcgkghr 1667 - 8333 mcgkgmin using weight at time of admission with an additional 2 mgkg 2000 mcgkg bolus of ketamine for sustained ICP elevations over 22mHg for greater than 5 minutes not attributed to other causes coughing etc In the control arm patients will receive their institutional analgosedation protocol The sedation protocols will be continued until removal of intracranial pressure monitoring
This study will take place during the participants hospital care The clinical team will administer treatment using standard practices including all safety precautions available Side effects will be monitored closely and may decide to discontinue the subjects participation in the study should the subjects health or safety are at risk
The research team will performed one outpatient follow-up after study intervention ends
Patients enrolled in the intervention arm will receive propofol at a rate of 300 mcgkghr 5 mcgkgmin with the addition of ketamine at a rate of 1000-5000 mcgkghr 1667 - 8333 mcgkgmin using weight at time of admission with an additional 2 mgkg 2000 mcgkg bolus of ketamine for sustained ICP elevations over 22mHg for greater than 5 minutes not attributed to other causes coughing etc In the control arm patients will receive their institutional analgosedation protocol The sedation protocols will be continued until removal of intracranial pressure monitoring
This study will take place during the participants hospital care The clinical team will administer treatment using standard practices including all safety precautions available Side effects will be monitored closely and may decide to discontinue the subjects participation in the study should the subjects health or safety are at risk
The research team will performed one outpatient follow-up after study intervention ends
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