The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 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 benefits of the method of dental sedation using Target controlled infusion (TCI) combined with Bispectral index (BIS) monitoring in patients with Mental Retardation and challenging behavior.
详细描述
The intravenous sedation of using of propofol is very effective for dental patients with Mental Retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedative depth because of the difficulty of verbal communication with them. Therefore, the infusion of excessive propofol dose elicits the complications and delay of recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Participants aged 16 or over,
- •American Society of Anesthesiologists (ASA) physical status 1 or 2
- •The treatments 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
- •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 times of eyelash reflex and eye opening
时间窗: 1 day
The time to going home
时间窗: 1 day
次要结局
未报告次要终点