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临床试验/NCT02942316
NCT02942316已完成不适用

Pupillary Dilation Reflex (PDR) Evaluation During General Anesthesia: a Pilot Study

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2016年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Pupillary Reflex Dilation

研究概览

简要总结

In this study, the pupillary dilation reflex is measured as a nociceptive indicator during elective abdominal surgery under general anesthesia.

详细描述

An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response of a nociceptive stimulus. This autonomic reflex, parasympathetic mediated in sedated patients, can be generated by various pain stimuli (built in standardized protocol, surgical incision, ...) The PDR is a robust reflex, even in patients under general anesthesia, and provides a potential evaluation of the autonomous circuit within the nociceptive evaluation based on pupil dilation upon A-delta and C fibers in both electrical or mechanic stimulation. This mono-centric project involving American Society of Anesthesiologists (ASA) classification I-II patients undergoing elective abdominal surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurements at four different standardized times.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

入选标准

  • Scheduled abdominal surgery

排除标准

  • History of eye deformity, invasive ophthalmologic surgery, impaired pupil reflex in advance
  • Kown cranial nerve(s) deficit
  • Infection of the eye
  • Predicted difficult airway management (DAF Guidelines)
  • Chronic opioid use (>3 months)
  • Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine

研究组 & 干预措施

Pupil dilation reflex measurement

Experimental

Four measurements of PDR during surgery at standardized times

干预措施: Pupil dilation reflex measurement (Device)

结局指标

主要结局

Pupillary Reflex Dilation

时间窗: Perioperative phase

Pupillary Reflex Dilation is measured four times intraoperatively as a possible indicator of success of analgesia

次要结局

  • Patient Movement(Perioperative phase)
  • Vital signs(Perioperative phase)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Davina Wildemeersch

MD

University Hospital, Antwerp

研究点 (2)

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