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(NCT03025906)

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 conducted this prospective randomized controlled trial to evaluate the relative efficacy and safety of intravenous (IV) phenobarbital (PB) and valproate (VPA) in patients with GCSE.
  • Drug: Phenobarbital
    In the PB group, a loading dose of 20 mg/kg (may give an additional 5-10 mg/kg) began at a rate of 50 mg/min followed by IV 100 mg q6 h.
    • Luminal
  • Drug: Valproate
    In the VPA group, a loading dose of 30 mg/kg (may give an additional 15 mg/kg) began at a rate of 3 mg/kg per min followed by a continuous infusion at a rate of 1-2 mg/kg per hour.
    • Depakine
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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.
After the failure of first-line diazepam treatment, patients with GCSE were randomized to receive either IV PB (standard doses, low rate) or VPA (standard). Successful treatment was considered when clinical and electroencephalographic seizure activity ceased. Adverse events following treatment and the neurological outcomes at discharge and 3 months later were also evaluated.
Status:
not yet recruiting
Type:
Interventional
Phase:
Start:
31 January, 2017
Updated:
15 January, 2017
Participants:
120
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