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A clinical study to note the effects of three drugs, phenytoin, valproate and levetiracetam in patients with convulsive status epilepticus

Efficacy of parenteral phenytoin, valproate and levetiracetam in the treatment of convulsive status epilepticus: a randomized controlled study - -

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/10/005141
Enrollment
150
Registered
2014-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients with convulsive status epilepticus. Recruited patients received i.v. lorazepam within 5 min. of arrival to the emergency services and then randomized into 3 groups.

Interventions

Intervention1: Phenytoin: group 1: The PHT group received intravenous phenytoin sodium (Epsolin) - 20 mg/kg (800-1600 mg) in 100 ml normal saline infused immediately at a rate of 50 mg/minute followed

Sponsors

NON FUNDED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consecutive patients presented to NIMHANS emergency services with convulsive SE (more than 30 minutes of continuous convulsive seizure activity or two or more sequential seizures without full recovery of consciousness in between seizures) 2. All underlying etiology of SE 3.All the 150 recruited patients with GCSE received intravenous lorazepam (0.1 mg/kg; 4-6 mg) within 5 minutes of arrival to the emergency services. 4.consented for the study 5.age group between 15-65 years were included

Exclusion criteria

Exclusion criteria: unwilling patients, patients presenting with non-convulsive SE, liver failure, renal failure, cardiac disease, pregnancy, requiring urgent neurosurgical intervention, H/O allergy to drugs, patients treated outside with AEDs.

Design outcomes

Primary

MeasureTime frame
Primary outcome was seizure controlTimepoint: Control of SE: a) No recurrence of seizures after 30 minutes of AED infusion with substantial improvement in sensorium over next 24 hours; or b) Sensorium did not improve substantially but EEG excluded NCSE.

Secondary

MeasureTime frame
Secondary outcomes were mortality, morbidity, side effects, and seizure control at 1 monthTimepoint: at discharge from hospital and at 1 month

Countries

India

Contacts

Public ContactSanjib Sinha

NIMHANS

mundlamuri.ravi@yahoo.com08026995150

Outcome results

None listed

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