Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus

Capital Medical University

Status and phase: Unknown; Phase 2

Conditions: Generalized Convulsive Status Epilepticus

Treatments: Drug: Phenobarbital; Drug: Valproate

Study type: Interventional

Funder types: Other

Identifiers

NCT03025906

WEIBANYIZHENGHAN[2012]649

Details and patient eligibility

About

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.

Full description

After the failure of first-line diazepam treatment, patients with GCSE are randomized to receive either IV PB (standard doses, low rate) or VPA (standard). Successful treatment is considered when clinical and electroencephalographic seizure activity ceases. Adverse events following treatment and the neurological outcomes at discharge and 3 months later are also evaluated.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Phenobarbital

Experimental group

Description:

In the PB group, a loading dose of 20 mg/kg (may give an additional 10 mg/kg) begins at a rate of 50 mg/min followed by IV 100 mg q6 h.

Treatment:

Drug: Phenobarbital

Valproate

Experimental group

Description:

In the VPA group, a loading dose of 30 mg/kg (may give an additional 15 mg/kg) begins at a rate of 3 mg/kg per min followed by a continuous infusion at a rate of 1-2 mg/kg per hour.

Treatment:

Drug: Valproate