Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus
关键词
抽象
描述
After the failure of first-line diazepam treatment, patients with GCSE are randomized to receive either IV PB (standard doses, low rate) or VPA (standard). Successful treatment is considered when clinical and electroencephalographic seizure activity ceases. Adverse events following treatment and the neurological outcomes at discharge and 3 months later are also evaluated.
日期
| 最后验证: | 06/30/2019 |
| 首次提交: | 11/14/2016 |
| 提交的预估入学人数: | 01/15/2017 |
| 首次发布: | 01/19/2017 |
| 上次提交的更新: | 07/07/2019 |
| 最近更新发布: | 07/08/2019 |
| 实际学习开始日期: | 02/15/2017 |
| 预计主要完成日期: | 09/30/2019 |
| 预计完成日期: | 11/30/2019 |
状况或疾病
干预/治疗
Drug: Phenobarbital
Drug: Valproate
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Phenobarbital In the PB group, a loading dose of 20 mg/kg (may give an additional 10 mg/kg) begins at a rate of 50 mg/min followed by IV 100 mg q6 h. | Drug: Phenobarbital In the PB group, a loading dose of 20 mg/kg (may give an additional 10 mg/kg) begins at a rate of 50 mg/min followed by IV 100 mg q6 h. |
| Experimental: Valproate In the VPA group, a loading dose of 30 mg/kg (may give an additional 15 mg/kg) begins at a rate of 3 mg/kg per min followed by a continuous infusion at a rate of 1-2 mg/kg per hour. | Drug: Valproate In the VPA group, a loading dose of 30 mg/kg (may give an additional 15 mg/kg) begins at a rate of 3 mg/kg per min followed by a continuous infusion at a rate of 1-2 mg/kg per hour. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. Number of patients with effective seizure control [One hour after the end of the PB or VPA loading dose]
次要成果指标
1. Mortality of patients [at 30 days and at 3 months]
2. Number of patients with post-SE symptomatic epilepsy [3 months]
3. The relapse rates of SE and nonconvulsive status epilepticus (NCSE) / nonconvulsive seizures (NCS) [in the first 24 h]
其他成果措施
1. Number of Participants With Adverse Events [From the administration of PB or VPA to 1 week]
