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临床试验/CTRI/2014/10/005141
CTRI/2014/10/005141已完成4 期

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

NON FUNDED1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年1月9日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Primary outcome was seizure control

研究概览

简要总结

Status epilepticus (SE) is a one of the neurological emergency with significant mortality and morbidity. The AEDs currently approved for management of SE after the usage of benzodiazepine, are phenytoin, fosphenytoin, sodium valproate cannot be administered often in patients with hepatic, renal or cardiac dysfunctions and most of these AEDs have potential drug interactions with concurrent AEDs or other medications. For the last few years, intravenous levetiracetam have been introduced in clinical practice and it has shown promising results in various retrospective studies. There are no systematic RCT comparing phenytoin, sodium valproate and levetiracetam after administering lorazepam in patients with generalized convulsive SE (GCSE). 

As per the current guidelines, once SE is refractory i.e. not controlled with benzodiazepines and another AED i.e. either phenytoin or valproate, it is advised to provide an ICU care with ventilator, with anaesthetic agents like midazolam, thiopentone or propofol. The benefits of such early treatment is unquestionable. But, the problems are non-availability of ventilatory ICU beds especially in resource poor settings like India; higher incidence of ICU infections; and anaesthetic medication induced side effects. Moreover, there is no definite evidence that aggressive treatment with anaesthetic agents in refractory SE will improve the outcome.

Therefore, this prospective study was conducted as a randomised controlled study to compare the efficacy of phenytoin, valproate sodium and levetiracetam along with lorazepam as first line in patients with GCSE at this centre.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
15.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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)
  • 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.

排除标准

  • 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.

结局指标

主要结局

Primary outcome was seizure control

时间窗: 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.

次要结局

  • Secondary outcomes were mortality, morbidity, side effects, and seizure control at 1 month(at discharge from hospital and at 1 month)

研究者

发起方
NON FUNDED
申办方类型
Other [NON-FUNDED TRIAL]

研究点 (1)

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