Crossover Randomized Clinical Trial to Evaluate the Effectiveness and Safety of Pupillometry as an Objective Measurement of Nociception in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Pupillary Dilatation Reflex (PDR)
研究概览
简要总结
Pupillometry has been used in healthy volunteers to investigate the usefulness of the pupil light reflex as an indicator of pain intensity on pressure as a nociceptive stimulus. In this sense, it is necessary to check if the pupillometry is sensitive to different types or sources of pain. One of these devices is the Algiscan® portable pupillometer (IdMed, Marseille, France), which we propose to use in the present study. This pupillometer has previously been used in healthy volunteers, and in patients admitted to the intensive care unit, subjected to mechanical ventilation and sedation / analgesia.
This study in healthy volunteers aims to evaluate whether the PDR can be a reliable and discriminatory measure of the intensity of nociception, applying various types of nociceptive stimuli. If so, this study could lead to the use of pupillometry as an objective measure of nociception in settings where patients cannot communicate, such as intensive care areas or perioperative settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of both sexes (balanced)
- •Caucasian race
- •Ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65)
- •Body weight within the normal range (Quetelet index: 19-30)
- •Clinical history, physical examination and vital signs within normality
- •Free acceptance to participate, with written informed consent
排除标准
- •Previous history of alcoholism or drug dependence (year prior to the screening visit or daily alcohol consumption> 40 gr / day for men or> 24 gr / day for women)
- •Significant consumption of stimulating drinks (> 5 coffees, teas, chocolate or cola drinks / day).
- •Taking any medication in the 15 days prior to the study and / or medicinal plants that may have an effect on the pupil (beta-blockers, droperidol, metoclopramide, clonidine ...). Oral contraceptives and paracetamol will be allowed.
- •Pregnancy (β-hCG test).
- •Menstruation and / or dysmenorrhea on the day of the study
- •Family or personal history or clinical evidence of psychiatric, neurological or ophthalmological problems: anxiety, depression, Parkinson's, glaucoma, dry eyes, retinal diseases, eye surgery and pupil abnormalities, presenting migraine pathology and diabetes
- •Pupillary diameter ≥ 5mm
- •Smokers or ex-smokers <6 months.
- •Have participated in a clinical trial in the 3 months prior to the start of this study.
结局指标
主要结局
Change in Pupillary Dilatation Reflex (PDR)
时间窗: Change in Pupillary Dilatation Reflex (PDR) from baseline to 50 minutes after tetanic stimulation (by Algiscan®)
Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)
次要结局
- Change in Pupillary Dilatation Reflex (PDR)(Change in Pupillary Dilatation Reflex (PDR) from baseline to +90 minutes after pressure estimulation)