Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- BIS value greater than 60 or lower than 40 during general anesthesia
研究概览
简要总结
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of propofol concentration for hypnosis under general anesthesia for young and elderly adults.
详细描述
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40 to 60) under general anesthesia for young and elderly adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18-28 or 65-75 years old
- •ASA physical status I or II
- •no pre-anesthetic medications prescribed
- •scheduled for surgery under general anesthesia
- •willing to participate and sign informed consent.
排除标准
- •Contraindications for propofol usage
- •history of neurologic or psychiatric diseases
- •drug abusers
- •users of drugs that alter central nervous system
- •pregnancy
- •emergency surgeries
- •rapid sequence intubation.
研究组 & 干预措施
Single Study Arm
All patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose.
干预措施: Propofol (Drug)
结局指标
主要结局
BIS value greater than 60 or lower than 40 during general anesthesia
时间窗: BIS value greater than 60 or lower than 40 during general anesthesia
BIS value greater than 60 or lower than 40 during general anesthesia
次要结局
未报告次要终点
研究者
Gabriel Magalhaes Nunes Guimaraes
Head of Anesthesiology
Brasilia University Hospital