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临床试验/NCT03280238
NCT03280238已完成不适用

Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers

Vrije Universiteit Brussel2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年3月1日最近更新:
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
19
试验地点
2
主要终点
Pupil dilation in relation to pain

研究概览

简要总结

Pain assessment is crucial in clinical practice. Currently, subjective self-report is considered the most appropriate method to evaluate pain. Although several methods to assess pain objectively exist, the lack of a golden standard still remains. This pilot study assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a measure of pain in healthy, conscious, male volunteers in a highly standardized and individualized environment. Nineteen subjects received three blocks of 4 individualized electrical stimulus intensities, ranging from no to severe pain. Subjects reported their perceived severity of each individual stimulus, enabling the comparison of changes in PD and ANI in relation to both administered stimulus intensities and perceived pain severities. PD and ANI were measured before and after each administration of a stimulus.

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 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • good health
  • no acute or chronic pain conditions
  • well rested

排除标准

  • chronic treatment
  • bad health
  • daily use of analgetics or other medication
  • weekly tobacco use
  • weekly use of recreational drugs
  • more than 10 alcohol consumptions a week

研究组 & 干预措施

Experiment

Experimental
  • Individualized painful electrical stimuli, Surpass LT stimulator (EMS Biomedical, Korneuburg, Austria) with a bipolar felt pad electrode
  • Measurement of pupil diameter, Algiscan® (iDMed, Marseille, France)
  • Measurement of Analgesia Nociception Index, PhysioDoloris® (MetroDoloris, Lille, France)

干预措施: Measurement of pupil dilation and analgesia nociception index (Diagnostic Test)

结局指标

主要结局

Pupil dilation in relation to pain

时间窗: 2sec before until 4sec after each painful stimulus

measurement of pupil dilation

次要结局

  • Analgesia nociception index in relation to pain(30sec before until 60sec after each painful stimulus)

研究者

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

Wendy Van Bogaert

Medical Student

Vrije Universiteit Brussel

研究点 (2)

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