NCT06432894招募中不适用
Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ANI values
研究概览
简要总结
The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 20-79 years under general anaesthesia with remimazolam
- •scheduled to undergo robotic surgery
- •in American Society of Anesthesiologists physical class 1, 2 or 3
- •voluntarily agree in writing to participate in this clinical study
排除标准
- •Conditions affecting the autonomic nervous system
- •other conditions or disease that may cause acute or chronic pain
- •the NRS before induction of anesthesia is 1 or over
- •When taking medications that may affect the autonomic nervous system
- •In other cases where the investigator deems the subject unsuitable for this trial
结局指标
主要结局
ANI values
时间窗: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
A value indicating the degree of pain calculated by ANI's algorithm
次要结局
- Heart Rate (HR) change(Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation)
- Blood Pressure change(Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation)
- Remimazolam infusion rate(During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change))
- Patient state index (PSI) change(Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation)
- Effect site concentration of remifentanil(During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change))
研究者
Jungmin Lee
Assistant Professor
Catholic Kwandong University
研究点 (1)
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