Measurement of Nociceptive Index During General Anesthesia in ASA 1-3 Patients Undergoing Elective Surgery Using the Nociception Level (NoL) Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Nociception level index (NoI)
研究概览
简要总结
Despite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. In a previous protocol the investigators measured pain responses during anesthesia based on single end-points, eg heart rate,blood pressure and pulse transit time. None of these parameters provided sufficient information regarding nociception. The investigators therefore want to further investigate this matter using a composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the magnitude of the autonomic response to painful stimuli. The NoL combines information from several physiological parameters, which represent different autonomic pathways. The multi-parameter approach empowered with state-of-the-art signal processing and machine learning techniques. In the current study the investigators will measure the NoL in ASA 1-3 patients undergoing elective surgery under general anesthesia. The investigators will measure NoL responses and the occurrence of patient movement upon the administration of a painful stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of the gastric tube, Insertion of the bladder catheter and Skin incision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years;
- •Sex: male or female;
- •Surgery: Any surgery under general anesthesia;
- •ASA status: 1, 2 or 3.
排除标准
- •Age: < 18 or > 80 years;
- •Unable to give written informed consent;
- •Pregnancy/lactation;
- •Extreme obesity: BMI > 35;
- •Perceived difficult intubation.
- •Patients requiring a rapid sequence induction
- •Patients on beta-blockers
研究组 & 干预措施
PROPOFOL ONLY GROUP
In this study group measurements will be obtained before intubation or opioid administration. To that end plasma propofol concentration will be increased slowly from 0 to 4 μg/ml in steps of 0.5 μg/mL. After the highest target is reached, the propofol target concentration will be lowered to get a BIS value of 50. After 5-min, the laryngoscope will be inserted into the mouth. Next the laryngoscope will be removed. After 5-min the laryngoscope will be placed again and the patient will be intubated. This will be done without additional administration of muscle relaxant.
干预措施: Propofol (Drug)
PROPOFOL + REMIFENTANIL TARGET A
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil.
干预措施: Propofol (Drug)
PROPOFOL + REMIFENTANIL TARGET A
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil.
干预措施: Remifentanil (Drug)
PROPOFOL + REMIFENTANIL TARGET B
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil
干预措施: Propofol (Drug)
PROPOFOL + REMIFENTANIL TARGET B
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil
干预措施: Remifentanil (Drug)
PROPOFOL + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil.
干预措施: Propofol (Drug)
PROPOFOL + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil.
干预措施: Remifentanil (Drug)
PROPOFOL + REMIFENTANIL TARGET D
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil.
干预措施: Propofol (Drug)
PROPOFOL + REMIFENTANIL TARGET D
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil.
干预措施: Remifentanil (Drug)
PROPOFOL + REMIFENTANIL TARGET E
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil.
干预措施: Propofol (Drug)
PROPOFOL + REMIFENTANIL TARGET E
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil.
干预措施: Remifentanil (Drug)
PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30.
干预措施: Propofol (Drug)
PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30.
干预措施: Remifentanil (Drug)
PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70.
干预措施: Propofol (Drug)
PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Nociception level index (NoI)
时间窗: Between induction and first incision
The NoL measures the magnitude of the autonomic responses to painful stimuli. The NoL combines information from several physiological parameters which represent different autonomic pathways.
次要结局
- Cardiovascular parameters(Between induction and first incision)
- Movement(Between induction and first incision)
- Depth of anesthesia(Between induction and first incision)
研究者
Albert Dahan
MD, PhD, Professor
Leiden University Medical Center