SuspendedPhase 4ketamine

Ketamine for Sedation in Severe Traumatic Brain Injury

Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine

NCT ID
NCT06429657
Target Enrollment
50 participants
Start Date
2024-09-23
Est. Completion
2027-06-30

About This Study

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.

Conditions Studied

Severe Traumatic Brain InjuryIntracranial HypertensionIntracranial Hemorrhage, Hypertensive

Interventions

  • Ketamine with propofol
  • Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* Adults 18-65 years of age
* Severe traumatic brain injury (TBI), with a Glasgow Coma Scale (GCS) ≤ 8, requiring intracranial monitoring
* Placement of intracranial pressure monitor
* Receiving treatment in an intensive care unit (ICU)

Exclusion Criteria:

* Significant cardiovascular disease with recent coronary intervention
* Pregnancy
* Prisoners
* Known allergy to ketamine or propofol

Study Locations (1)

Brooke Army Medical Center
Fort Sam Houston, Texas, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source