Nociceptive Pain, Pupillary Light Reflex Lost, Healthy, Pain, Procedural, Gender, Anxiety
Conditions
Brief summary
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.
Interventions
DEVICECE marked medical device
Tetanic stimulation
DEVICEAlgometer
Pressure stimulation
PROCEDUREComparator
Non-nociceptive procedure (fine touch)
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects of both sexes (balanced) 2. Caucasian race 3. Ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65) 4. Body weight within the normal range (Quetelet index: 19-30) 5. Clinical history, physical examination and vital signs within normality 6. Free acceptance to participate, with written informed consent
Exclusion criteria
1. 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) 2. Significant consumption of stimulating drinks (\> 5 coffees, teas, chocolate or cola drinks / day). 3. 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. 4. Pregnancy (β-hCG test). 5. Menstruation and / or dysmenorrhea on the day of the study 6. 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 7. Pupillary diameter ≥ 5mm 8. Smokers or ex-smokers \<6 months. 9. Have participated in a clinical trial in the 3 months prior to the start of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pupillary Dilatation Reflex (PDR) | Change in Pupillary Dilatation Reflex (PDR) from baseline to +10 minutes (with non-nociceptive procedure (fine touch)) | Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pupillary Dilatation Reflex (PDR) | Change in Pupillary Dilatation Reflex (PDR) from baseline to + 60 minutes after pressure estimulation | Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®) |
Countries
Spain
Outcome results
None listed