Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain Scores on a 0-10 Numeric Rating Scale (NRS)
研究概览
简要总结
The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.
详细描述
Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.
Assessment of the performance of ANI to detect NRS>3 and NRS>=7 by building ROC curves.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgical or endoscopic procedures performed on general anesthesia
排除标准
- •age <18 yrs or >75 yrs
- •arrythmia
- •administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
- •psychiatric diseases
- •autonomic nervous system (ANS) disorders
- •inability to understand the verbal rating pain scale.
结局指标
主要结局
Pain Scores on a 0-10 Numeric Rating Scale (NRS)
时间窗: At arrival in PACU or 10 min after extubation
Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS\<3 corresponds to no or mild pain NRS\>=3 corresponds to moderate to severe pain NRS\>=7 corresponds to severe pain
Analgesia/Nociception Index (ANI)
时间窗: At arrival in post-operative care unit (PACU) or 10 min after extubation
The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.
次要结局
未报告次要终点
研究者
Emmanuel Boselli
MD, PhD
Hôpital Edouard Herriot