Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

NCT04864340 | Unknown

• 1 other identifier: IIBSP-PUP-2019-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Change in Pupillary Dilatation Reflex (PDR)

  Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan®

  Change in Pupillary Dilatation Reflex (PDR) from baseline to +10 minutes (with non-nociceptive procedure (fine touch))

• Change in Pupillary Dilatation Reflex (PDR)

  Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)

  Change in Pupillary Dilatation Reflex (PDR) from baseline to 20 minutes after tetanic stimulation (by Algiscan®)

• Change in Pupillary Dilatation Reflex (PDR)

  Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)

  Change in Pupillary Dilatation Reflex (PDR) from baseline to 30 minutes after tetanic stimulation (by Algiscan®)

• Change in Pupillary Dilatation Reflex (PDR)

  Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)

  Change in Pupillary Dilatation Reflex (PDR) from baseline to 40 minutes after tetanic stimulation (by Algiscan®)

• Change in Pupillary Dilatation Reflex (PDR)

  Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)

  Change in Pupillary Dilatation Reflex (PDR) from baseline to 50 minutes after tetanic stimulation (by Algiscan®)

Secondary Outcomes (4)

• Change in Pupillary Dilatation Reflex (PDR)

  Change in Pupillary Dilatation Reflex (PDR) from baseline to + 60 minutes after pressure estimulation

• Change in Pupillary Dilatation Reflex (PDR)

  Change in Pupillary Dilatation Reflex (PDR) from baseline to +70 minutes after pressure estimulation

• Change in Pupillary Dilatation Reflex (PDR)

  Change in Pupillary Dilatation Reflex (PDR) from baseline to +80 minutes after pressure estimulation

• Change in Pupillary Dilatation Reflex (PDR)

  Change in Pupillary Dilatation Reflex (PDR) from baseline to +90 minutes after pressure estimulation

Study Arms (5)

threshold stimulation (tetanic)

EXPERIMENTAL

Device: CE marked medical device

upper threshold stimulation (tetanic)

EXPERIMENTAL

Device: CE marked medical device

threshold stimulation (pressure)

EXPERIMENTAL

Device: Algometer

upper threshold stimulation (pressure)

EXPERIMENTAL

Device: Algometer

non nociceptive procedure (fine touch)

PLACEBO COMPARATOR

Procedure: Comparator

Interventions

CE marked medical device DEVICE

Tetanic stimulation

threshold stimulation (tetanic); upper threshold stimulation (tetanic)

Algometer DEVICE

Pressure stimulation

threshold stimulation (pressure); upper threshold stimulation (pressure)

Comparator PROCEDURE

Non-nociceptive procedure (fine touch)

non nociceptive procedure (fine touch)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Nociceptive Pain; Pain, Procedural; Coitus; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 28, 2021
• Study Start: April 30, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

ES (1)