Ketamine for the Treatment of Refractory Status Epilepticus

ConditionRefractory Status Epilepticus

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorThomas Jefferson University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years of age or older

Patients with refractory status epilepticus unresponsive to appropriately dosed first line agents administered intravenous or intraosseous and one second line agent

First line agents: lorazepam, midazolam, or diazepam

Second line agents: phenytoin (20 mg/kg), valproate (40 mg/kg), levetiracetam (60 mg/kg), lacosamide (400 mg)

Disqualifiers

Exclusively psychogenic non epileptic seizures

Pregnant individuals

Incarcerated individuals

Patients with hypersensitivity to ketamine or any component of the formulation

Trial design

Design model

Parallel

Treatments tested in this trial

Ketamine
Drug
Timing of ketamine initiation will differ between groups (early versus late ketamine)
Midazolam
Drug
Midazolam infusion will be initiated at the same time in both groups

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Early ketamineActive comparator 2 interventions

Group B: Late ketamineActive comparator 2 interventions

Trial outcomes

Primary outcomes

Time to seizure cessation

Time from initiation of anesthetic infusion (midazolam or midazolam plus ketamine) to the time of last electrographic seizure

Time frame

72 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: