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.
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.
Continuous IV analgosedation with propofol infusion plus ketamine infusion and bolus for refractory intracranial hypertension.
Infusion 1000–5000 mcg/kg/hr (≈1.0–5.0 mg/kg/hr); additional 2 mg/kg bolus (for ICP>22 mmHg >5 min).
Propofol infusion at 300 mcg/kg/hr (5 mcg/kg/min) per institutional protocol; titrated to clinical effect.
Institutional analgosedation per SOC (propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam).
Standard-of-care analgosedation using institutional agents (propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam) administered per local protocol.