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Sodium valproate versus diazepam in generalized convulsive status epilepticus in adults: a prospective randomized controlled trial

Sodium valproate versus diazepam in generalized convulsive status epilepticus in adults: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000577
Enrollment
Unknown
Registered
2009-11-01
Start date
2007-02-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized convulsive status epilepticus

Interventions

group A:Diazepam 10mg intravenous, followed by infusion at the initial rate of 4mg/h, then increased by 4mg every 5min until SE is controlled or persisting for1 hour
group B:Sodium valproate 30mg/kg intravenous, followed by infusion at the rate of 1-2mg/kg/h

Sponsors

Xuanwu Hospital of the Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male and female aged 15 years old and over; 2. The authorized principal is able and willing to provide signed informed consent; 3.Generalized convulsive status epilepticus, meeting the criterion formulated by Epilesy Foundation of America's Working Group on Status Epilepticus in 1993: More than 30 minutes of continuous seizure activity or two or more sequential seizures without full recovery of consciousness between seizures.

Exclusion criteria

Exclusion criteria: 1. Pregnant women or lactating parturient; 2. Cranium trauma; 3. Systemic disease: liver and/or kidney function insufficiency; 4. Allergic to target drug (sodium valproate or diazepam).

Design outcomes

Primary

MeasureTime frame
Times of breakthrough seizures within 24 hours;Time interval between starting the study drug and the control of SE;Response rate;

Secondary

MeasureTime frame
The neurological outcome;

Countries

China

Contacts

Public ContactYingying Su
suyingyingtang@sina.com+86 15901361953

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026