A clinical study to note the effects of three drugs, phenytoin, valproate and levetiracetam in patients with convulsive status epilepticus
Phase 4
Completed
- 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.
- Registration Number
- CTRI/2014/10/005141
- Lead Sponsor
- ON FUNDED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary outcomes were mortality, morbidity, side effects, and seizure control at 1 monthTimepoint: at discharge from hospital and at 1 month