Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pupillary diameter
研究概览
简要总结
Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who has reached puberty
- •ASA I or II who is scheduled for elective surgery under general anesthesia
排除标准
- •neurologic, metabolic, ocular disease
- •chronic pain
- •under medication that interferes with autonomic nervous system
- •patient requiering a rapid sequence induction
研究组 & 干预措施
Propofol 3 µg/ml
Patients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
干预措施: Propofol (Drug)
Propofol 3 µg/ml
Patients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
干预措施: Pupillary diameter measurement (Device)
Propofol 1 µg/ml
Patients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
干预措施: Propofol (Drug)
Propofol 1 µg/ml
Patients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
干预措施: Pupillary diameter measurement (Device)
Propofol 2 µg/ml
Patients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
干预措施: Propofol (Drug)
Propofol 2 µg/ml
Patients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
干预措施: Pupillary diameter measurement (Device)
结局指标
主要结局
Pupillary diameter
时间窗: Instantaneous measure, 10 minutes after the beginning of the study period
次要结局
- Bispectral Index (BIS)(continuous measure, recorded10 minutes after the beginning of the study period)
- Observer's Assessment of Alertness/Sedation Scale (OAAS)(10 minutes after the beginning of the study)
- Heart rate(continuous measure, recorded10 minutes after the beginning of the study period)
研究者
Pr Isabelle CONSTANT
Professor
Hôpital Armand Trousseau