Status:
UNKNOWN
Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Nociceptive Pain
Pupillary Light Reflex Lost
Eligibility:
All Genders
25-65 years
Phase:
NA
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 n...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04864340
Start Date
April 30 2021
End Date
May 1 2021
Last Update
May 19 2021
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041