Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial) (FAST)
Non-Convulsive Status Epilepticus
About this trial
This is an interventional treatment trial for Non-Convulsive Status Epilepticus
Eligibility Criteria
Inclusion Criteria:
- Adult patients (older than 18 years) with EEG-verified NCSE, according to the Salzburg criteria, who have not responded to appropriate treatment with benzodiazepines and at least one 2nd line i.v. anti-seizure medication according to the current Danish national neurological treatment guidelines (Levetiracetam, Fosfenytoin or Valproate).
Exclusion Criteria:
- patients with epilepticus status due to acute neuroinfection (e.g. bacterial meningitis or viral encephalitis)
- acute traumatic or spontaneous intracranial hemorrhage
- suspicion of cerebral anoxia / hypoxia / hypoglycemia / epileptic encephalopathy
- contraindications to anti-seizure medication defined in the protocol
- contraindications to anesthesia treatment in intensive care
- focal motor status epilepticus without relevant conscious influence (Glasgow Coma Scale> 13)
- known epileptic encephalopathy
- Clinical need for acute intubation
Sites / Locations
- Aarhus Universitetshospital
- Rigshospitalet
- Odense University HospitalRecruiting
- University Hospital of ZealandRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
"Non-sedative medical treatment"
Fast sedation
The patient is treated with an additional high-dose intravenous antiepileptic drug, which is selected by the treating neurologist. If NCSE continues to be detected at cEEG or clinically> 3 hours after starting treatment, the patient should receive standard treatment (i.e. sedation in the intensive care unit or addition of additional intravenous antiepileptic drugs) in accordance with local guidelines and the assessment of the treating neurologist. The following preparations are permitted as additional treatment: Levetiracetam (60 mg / kg as saturation dose followed by maintenance dose of 2-4 g / day), valproate (60 mg / kg as saturation dose followed by maintenance dose of 20 mg / kg / day), phosphenytoin (20 PE as saturation dose followed by maintenance dose 5 mg PE / kg / day), lacosamide (400 mg as a saturation dose followed by a maintenance dose of 200-400 mg / day), topiramate (200-400 mg per probe as a saturation dose followed by a maintenance dose of 200-400 mg / day).
Within a maximum of 60 minutes after the diagnosis of NCSE (EEG or clinical), the patient must be sedated with 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. After 20 hours, the sedation should be completely phased out within 3 hours.