NCT04864340

Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	CE marked medical device	Tetanic stimulation
DEVICE	Algometer	Pressure stimulation
PROCEDURE	Comparator	Non-nociceptive procedure (fine touch)

Timeline

• Start date: 2021-04-30
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2021-04-28
• Last updated: 2021-05-19

Locations

1 site across 1 country: Spain