SuspendedPhase 4

Ketamine for Sedation in Severe Traumatic Brain Injury

Stopped: administrative hold at current open site and awaiting site startup at additional participating sites

United States50 participantsStarted 2024-09-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of ICP elevations greater than 22 mmHg for greater than 5 minutes

Timeframe: During the maximum 5-day course of study intervention, while patient is sedated and has intracranial pressure monitor in place in the ICU setting

Mean ICP

Timeframe: During the maximum 5-day course of study intervention.

Trial details

NCT IDNCT06429657

SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

View on ClinicalTrials.gov More Severe Traumatic Brain Injury trials