Clinical TrialTraumatic Brain Injury (TBI)KetamineTemporarily not available

Ketamine for Sedation in Severe Traumatic Brain Injury (Ketamine)

This open-label randomized trial (n=50) will assess the safety of ketamine plus propofol sedation versus standard-of-care analgosedation in ICU patients with severe TBI.

Target Enrollment
50 participants
Study Type
Phase IV interventional
Design
Randomized

Detailed Description

Open-label, randomized, parallel-group Phase IV trial comparing continuous IV ketamine added to propofol versus institutional standard-of-care analgosedation for adults with severe traumatic brain injury requiring intracranial pressure monitoring.

Experimental arm: propofol infusion (≈300 mcg/kg/hr) with ketamine infusion (1000–5000 mcg/kg/hr) and additional 2 mg/kg bolus for sustained ICP >22 mmHg; SOC arm receives local analgosedation per protocol. Safety, ICP control, and clinical outcomes assessed during hospital stay with one outpatient follow-up.

Study Arms & Interventions

Ketamine + propofol

experimental

Continuous IV analgosedation with propofol infusion plus ketamine infusion and bolus for refractory intracranial hypertension.

Interventions

  • Ketamine2 mg/kg
    via IV• infusion and bolus

    Infusion 1000–5000 mcg/kg/hr (≈1.0–5.0 mg/kg/hr); additional 2 mg/kg bolus (for ICP>22 mmHg >5 min).

  • Compound
    via IV• continuous infusion

    Propofol infusion at 300 mcg/kg/hr (5 mcg/kg/min) per institutional protocol; titrated to clinical effect.

Standard of care

active comparator

Institutional analgosedation per SOC (propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam).

Interventions

  • Compound
    via IV

    Standard-of-care analgosedation using institutional agents (propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam) administered per local protocol.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • Exclusion Criteria:
  • Significant cardiovascular disease with recent coronary intervention
  • Pregnancy
  • Prisoners
  • Known allergy to ketamine or propofol

Study Details

  • Status
    Temporarily not available
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment50 participants
  • Timeline
    Start: 2024-06-01
    End: 2027-06-30
  • Compound
    Ketamine
  • Topic
    Traumatic Brain Injury (TBI)

Locations

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

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