Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

Healthy Clinical Trial

Official title:

Crossover Randomized Clinical Trial to Evaluate the Effectiveness and Safety of Pupillometry as an Objective Measurement of Nociception in Healthy Volunteers.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864340
• Other study ID #: IIBSP-PUP-2019-01
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: May 2021

Study information

• Verified date: May 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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 (ß-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.

Related Conditions & MeSH terms

• Anxiety
• Gender
• Healthy
• Nociceptive Pain
• Pain, Procedural

Intervention

Device:
• CE marked medical device
Tetanic stimulation
• Algometer
Pressure stimulation

Procedure:
• Comparator
Non-nociceptive procedure (fine touch)

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Primary	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®)
Primary	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®)
Primary	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®)
Primary	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	Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to + 60 minutes after pressure estimulation
Secondary	Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +70 minutes after pressure estimulation
Secondary	Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +80 minutes after pressure estimulation
Secondary	Change in Pupillary Dilatation Reflex (PDR)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +90 minutes after pressure estimulation