Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency, evidence-based data to guide initial drug treatment choices are lacking in the Chinese population. The investigators conduct this prospective randomized controlled trial to evaluate the relative efficacy and safety of intravenous (IV) phenobarbital (PB) and valproate (VPA) in patients with GCSE.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xuanwu Hospital, Beijing
• Treatments: Phenobarbital; Valproic Acid

Criteria

Inclusion Criteria:

• All consecutive GCSE patients (after the failure of first-line diazepam treatment) who were admitted in the emergency room or neurocritical care unit in Xuanwu Hospital of Capital Medical University.

Exclusion Criteria:

• Unstable vital signs, such as a systolic blood pressure of <90 mm Hg, a pulse of <60 beats per min, or an arterial blood oxygen saturation of <90%,

• Liver dysfunction (alanine transaminase or total bilirubin of more than twice the normal upper limit),

• Neurologic emergency requiring immediate surgical intervention,

• Pregnancy or breast feeding,

• Hypersensitivity to study drugs.