Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Recruiting
CT.gov ID
NCT04864340
Collaborator
(none)
30
1
5
1
913.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CE marked medical device
  • Device: Algometer
  • Procedure: Comparator
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Crossover Randomized Clinical Trial to Evaluate the Effectiveness and Safety of Pupillometry as an Objective Measurement of Nociception in Healthy Volunteers.
Actual Study Start Date :
Apr 30, 2021
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: threshold stimulation (tetanic)

Device: CE marked medical device
Tetanic stimulation

Experimental: upper threshold stimulation (tetanic)

Device: CE marked medical device
Tetanic stimulation

Experimental: threshold stimulation (pressure)

Device: Algometer
Pressure stimulation

Experimental: upper threshold stimulation (pressure)

Device: Algometer
Pressure stimulation

Placebo Comparator: non nociceptive procedure (fine touch)

Procedure: Comparator
Non-nociceptive procedure (fine touch)

Outcome Measures

Primary Outcome Measures

  1. 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®

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

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

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

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

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

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

  5. Change in Pupillary Dilatation Reflex (PDR) [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®)

Secondary Outcome Measures

  1. 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®)

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

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)

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

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)

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

    Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT04864340
Other Study ID Numbers:
  • IIBSP-PUP-2019-01
First Posted:
Apr 28, 2021
Last Update Posted:
May 19, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2021