The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The dose of anesthesia agent
研究概览
简要总结
The aim of this study is to evaluate the effect of valproate on the required dose of propofol for sedation in patients with mental retardation.
详细描述
The intravenous sedation with propofol is very useful for patients with mental retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedation depth because of the difficulty of verbal communication with them. Most of them have a epilepsy and take antiepileptic drugs. Antiepileptic drugs are thought to influence on the effect of anesthetics. Valproate is reported to inhibit the metabolism of propofol. Therefore, we divide the patients into two groups : patients receiving valproate (valproate group), patients receiving no antiepileptic drugs (control group), and compare the required dose of propofol and the recovery time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16 or over
- •American Society of Anesthesiologists (ASA) physical status 1 or 2
- •The treatment of dental caries, endodontics, periodontics and prosthesis were planed
- •Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment
排除标准
- •Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons
- •Patients needed premedication and inhalational anesthetics
- •Patients had uncontrolled or sever medical condition
结局指标
主要结局
The dose of anesthesia agent
时间窗: 1 day
The recovery time of eyelash reflex
时间窗: 1 day
The recovery time of eye opening
时间窗: 1 day
次要结局
未报告次要终点