Early Ketamine Plus Midazolam Versus Ketamine Plus Midazolam for the Treatment of Refractory Status Epilepticus
Thomas Jefferson University
Summary
This pilot feasibility study aims to examine how the timing of ketamine introduction as a third-line anti-seizure medication infusion relates to seizure cessation in patients with refractory status epilepticus (RSE).
Description
Patients admitted to the Jefferson Neurological Intensive Care Unit with seizures or status epilepticus will be screened for eligibility. Surrogate consent will be obtained from the participants legally authorized representative (LAR) by study personnel for eligible patients using remote e-consent process via RedCap. Participants will be randomized 1:1 to receive either early intravenous ketamine plus midazolam infusion or the current institutional protocol of midazolam followed by late ketamine infusion (Fernandez et al., 2018). Continuous video EEG monitoring will guide medication titration,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults 18 years of age or older 2. Patients with refractory status epilepticus unresponsive to appropriately dosed first line agents administered intravenous or intraosseous and one second line agent 1. First line agents: lorazepam, midazolam, or diazepam 2. Second line agents: phenytoin (20 mg/kg), valproate (40 mg/kg), levetiracetam (60 mg/kg), lacosamide (400 mg) 3. All etiologies of status epilepticus will be included Exclusion Criteria: 1. Exclusively psychogenic non epileptic seizures 2. Pregnant individuals 3. Incarcerated individuals 4. Patients with hy…
Interventions
- DrugKetamine
Timing of ketamine initiation will differ between groups (early versus late ketamine)
- DrugMidazolam
Midazolam infusion will be initiated at the same time in both groups
Location
- Thomas Jefferson University HospitalPhiladelphia, Pennsylvania