Ketamine for Sedation in Severe Traumatic Brain Injury

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status and phase: Suspended; Phase 4

Conditions: Intracranial Hemorrhage, Hypertensive; Intracranial Hypertension; Severe Traumatic Brain Injury

Treatments: Drug: Ketamine with propofol; Other: Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06429657

C.2024.025

Details and patient eligibility

About

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.

Full 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 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) 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 participant's 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 subject's participation in the study should the subject's health or safety are at risk.

The research team will performed one outpatient follow-up after study intervention ends.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Ketamine with propofol

Experimental group

Description:

Propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine

Treatment:

Drug: Ketamine with propofol

SOC propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam

Active Comparator group

Description:

Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam.

Treatment:

Other: Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam