Ibaraki ER Network Epilepsy Control Trial with LevetIracetam vs. FosphEnytoine

JRCT ID: jRCTs031190160

Registered date:16/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: status epilepticus
• Date of first enrollment: 25/12/2019
• Target sample size: 176
• Study type: Interventional

Intervention(s)

At first, diazepam 1 - 20 mg is given in both groups.
Hosphenytoin group
After diazepam, hosphenytoin 22.5mg/kg+normal saline 100ml is given DIV by under 3mg/kg/min or 150mg/min
Levetiracetam group
After diazepam, levetiracetam 1000-3000mg is given DIV by 2-5mg/kg/min

Outcome(s)

• Primary Outcome: seizure stop within 30 min from start of study drugs administration

Secondary Outcome

seizure reccurence within 24 h
severe adverse events
intubation rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

status epilepticus with convulsion, who were transfered by ambulance
The difinition of status epilepticus is as follows; over 5 minutes of continuous seizures, or over 2 minutes discrete seizures between which there is incomplete recovery of consciousness over JCS II-30
exclude non-convulsive seizure

Exclude criteria

under 20 years old
patients who entried this study in the past
patients in whom informed consent can not be obtained from proxies (If proxies can not be found, the study is performed and the consent is obtained after action.
already intubated patients before treatment
allergy to fosphenytoin or levetiracetam
pregnancy
pseudo-seizure
medical doctor considered inapropriate

Related Information

• Primary Sponsor: Inoue Yoshiaki
• Source(s) of Monetary Support: Japanese Association for Acute Medicine