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临床试验/NCT04154410
NCT04154410已完成不适用

Prospective Observational Study of the Non Invasive Objective Assessment of Pre-operative Anxiety Using the Heart Rate Variability and the Pupillary Reflex Measurement

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2022年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
1
主要终点
Analgesia Nociception Index (ANI)

研究概览

简要总结

The purpose of this study is to determine whether heart rate variability levels and pupillometric measures are effective objective predictors of anxiety among patients before surgery.

详细描述

The prevalence of preoperative anxiety in adults is estimated between 60 and 80% and prevents a good integration of the information delivered, while seeking more attention from caregivers. In addition, anxious patients require the administration of higher doses of hypnotics at anesthetic induction. The pain expressed in the postoperative period is proportional to preoperative anxiety, with a slower recovery kinetics responsible for prolonged stay in the recovery room. Finally, the incidence of chronic pain is correlated with the intensity of preoperative anxiety.

While the recommendations of the European Anesthesia Society (ESA) emphasize the importance of managing preoperative anxiety, this dimension is often overlooked and existing methods of assessment are time consuming and sometime inaccurate.

Objective screening with dynamic monitoring of the level of anxiety in real time is the necessary step to ensure accurate detection and personalized management of the emotional state of patients before performing an invasive procedure.

Anxiety is an emotional state reflecting an imbalance of cortico-frontal regulation on the limbic system. The interaction between these two neuronal systems is expressed in particular by the intensity of the vagal tone and the autonomic nervous system. Exploring the balance between sympathetic and parasympathetic systems is a promising avenue of exploration for identifying, predicting, and treating anxiety.

Two reliable and easy-to-use devices analyzing the expression of the autonomic nervous system validated in the analysis of nociception in the awake patient or under general anesthesia are marketed:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Day case surgical patients

排除标准

  • psychiatric disorders
  • participating refusal

结局指标

主要结局

Analgesia Nociception Index (ANI)

时间窗: at Day 0

Index from 0 to 100 Variation 5 minutes before during and 5 minutes after cannulation Comparison between anxious and non-anxious patients Measure of anxiety reduction

次要结局

  • Visual Analog Scale (VAS)(at Day 0 - after 30 minutes immersive light intervention)
  • Heart rate variability(at Day 0)
  • Coefficient of variation of pupillary diameter (CVDP)(at Day 0)
  • Analgesia Nociception Index (ANI)(at Day 0 - after 30 minutes immersive light intervention)
  • Visual Analog Scale (VAS)(at Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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