Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

NCT ID: NCT04864340

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2021-05-31

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.

Conditions

Nociceptive Pain; Pupillary Light Reflex Lost; Healthy; Pain, Procedural; Gender; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

threshold stimulation (tetanic)

Group Type: EXPERIMENTAL

CE marked medical device

Intervention Type: DEVICE

Tetanic stimulation

upper threshold stimulation (tetanic)

Group Type: EXPERIMENTAL

CE marked medical device

Intervention Type: DEVICE

Tetanic stimulation

threshold stimulation (pressure)

Group Type: EXPERIMENTAL

Algometer

Intervention Type: DEVICE

Pressure stimulation

upper threshold stimulation (pressure)

Group Type: EXPERIMENTAL

Algometer

Intervention Type: DEVICE

Pressure stimulation

non nociceptive procedure (fine touch)

Group Type: PLACEBO_COMPARATOR

Comparator

Intervention Type: PROCEDURE

Non-nociceptive procedure (fine touch)

Interventions

CE marked medical device

Tetanic stimulation

Intervention Type: DEVICE

Algometer

Pressure stimulation

Intervention Type: DEVICE

Comparator

Non-nociceptive procedure (fine touch)

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Maria Rosa Ballester, PhD

Role: primary

mballesterv@santpau.cat

Role: backup

+34935537855

Other Identifiers

IIBSP-PUP-2019-01

Identifier Type: -

Identifier Source: org_study_id