Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)

Condition(s) studied

Investigational drug(s) / intervention(s)

Rapid sedation: High-dose Propofol (bolus 3-5 g / kg, maintenance dose 5-10 mg / kg / hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg / kg / h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone.

Study summary

This open-label, randomized multicenter trial aims at clarifying the standard of care of patients with non-convulsive status epilepticus not responding to treatment with benzodiazepines and at least one high-dose intra venous anti-seizure medication.

Eligibility

Primary outcome measure(s)

• Proportion of patients with continued NCSE on EEG after 24 h ("treatment failure") — 24 hours after randomisation
  NCSE diagnosed using EEG and defined by the "Salzburg criteria" for NCSE (e.g. Leitinger et al. Lancet Neurology, 2016)

Trial sites (5)

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