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临床试验/NCT03867955
NCT03867955已完成不适用

Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia. Prospective, Monocentric, Observational Compendium

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月1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
30
试验地点
1
主要终点
slope (or rate) of pupil diameter change

研究概览

简要总结

Pupillary diameter monitoring is currently used routinely for assessment of the nociception / antinociception balance during surgery.

Pupillary diameter decreases reflexively in response to light flash, called photomotor reflex. The photomotor reflex is described by the latency between the light flash and the beginning of the decay expressed in milliseconds, the slope or decay rate expressed in millimeters per second, and the percentage of variation, corresponding to the ratio between the basal pupil diameter and the minimum diameter reached during the light stimulation.

The AlgiScan™ videopupillometer used includes a device for producing a flash light, designed for this purpose.

It has recently been shown that the slope (or rate) of pupillary diameter decrease during a light flash varies during anesthesia, independently of any nociceptive stimulus.

详细描述

The hypothesis of this study is the variation of the decay slope of the pupil diameter is proportional to the depth of the anesthesia.

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

  • Majors patients
  • Score American Society of Anesthesiologists (ASA) 1 or 2
  • Managed in the operating theater of the University Hospital of Saint-Etienne for a neurosurgical intervention.

排除标准

  • Single or bilateral eye surgery modifying the possibilities of variation of the pupillary diameter
  • Having been asleep under general anesthesia in the 7 days prior to the current surgery
  • History of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomous stage

结局指标

主要结局

slope (or rate) of pupil diameter change

时间窗: Day 0

To compare the slope (or rate) of pupil diameter change obtained during a standardized 320 Lux light flash and the depth of anesthesia evaluated by the Bispectral Index (BIS™) at different levels of depth of anesthesia.

次要结局

  • latency and the amplitude of pupillary diameter reduction(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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