The Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus Under Steady-state Remifentanil Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Post-stimulation Pupillary reflex dilation
研究概览
简要总结
A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for an idiopathic scoliosis surgical correction
排除标准
- •Ophtalmologic pathology
- •Neurologic or muscular pathology
- •Metabolic pathology
- •Chronic pain
研究组 & 干预措施
BIS 55
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 55 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: Remifentanil (Drug)
BIS 55
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 55 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: propofol (Drug)
BIS 55
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 55 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: TCI (Device)
BIS 55
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 55 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: Tetanic stimulation (Procedure)
BIS 55
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 55 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: Algiscan (Device)
BIS 25
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 25 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: Remifentanil (Drug)
BIS 25
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 25 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: propofol (Drug)
BIS 25
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 25 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: TCI (Device)
BIS 25
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 25 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: Tetanic stimulation (Procedure)
BIS 25
- Induction:
TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 25 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)
干预措施: Algiscan (Device)
结局指标
主要结局
Post-stimulation Pupillary reflex dilation
时间窗: 30 seconds
percentage of dilation compared to pre-stimulation pupillary diameter
次要结局
未报告次要终点
研究者
Pr Isabelle CONSTANT
Professor Isabelle COnstant
Hôpital Armand Trousseau