Anesthesia Feasibility Study With the CONCERT-CL® Station: Administration of Hypnotic in Closed Loop and Administration of Morphine in TCI Mode, at Constant Concentration, After Initial Calibration With a Pupillometer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station
研究概览
简要总结
This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram, to maintain the hypnosis level within the recommended limits for general anesthesia. The analgesic agent is administered in "Target-Controlled Infusion = TCI" and analgesia evaluated by pupillometry.
This is a prospective, open, non-controlled, non-randomized, monocentric study. The main objective is to study the potential contribution of the system in the conduct of anaesthesia, as decision support, for the administration of the hypnotic agent.
Secondary objectives will include hemodynamic stability, and the average concentrations of opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.
The study will involve surgical patients scheduled for surgery under general anesthesia for more than 1 (one) hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women aged 18 years old and over
- •Surgery of any type programmed for longer than 1 hour
- •Anesthesia combining three agents: hypnotic, morphine, curare
排除标准
- •minor patient
- •pregnant and lactating women
- •Known or suspected hypersensitivity to propofol,
- •known or suspected hypersensitivity to remifentanil and other fentanyl derivatives,
- •known or suspected hypersensitivity to rocuronium and atracurium, preventing the use of the two products.
- •peanut allergy, soy, Egg
- •neurological disease history with known modification of the electroencephalogram
- •severe eye disease, ocular implant, standing diabetes with diabetic retinopathy
- •pacemakers patient
- •surgery whose position is not suitable for a monitoring on the ulnar nave
- •general anesthesia associated with regional anesthesia
- •Simultaneous use of shortwave therapy or microwave
- •Simultaneous use of high frequency surgical apparatus
- •15 patients under supervision or unable to consent
- •patient undergoing psychiatric care
- •patient in a health or social institution
- •emergency
结局指标
主要结局
During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station
时间窗: From start of anesthesia until the release of the patient from recovery room
The evaluation will measure the level of hypnosis during surgery. =\> The performance of the closed loop of the CONCERT-CL® station will be evaluated by studying its overall score (GS).
次要结局
未报告次要终点