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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| threshold stimulation (tetanic) | Experimental |
| |
| upper threshold stimulation (tetanic) | Experimental |
| |
| threshold stimulation (pressure) | Experimental |
| |
| upper threshold stimulation (pressure) | Experimental |
| |
| non nociceptive procedure (fine touch) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE marked medical device | Device | Tetanic stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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®) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Pupillary Dilatation Reflex (PDR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08041 | Spain |
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| Algometer | Device | Pressure stimulation |
|
| Comparator | Procedure | Non-nociceptive procedure (fine touch) |
|
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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D059226 | Nociceptive Pain |
| D000073818 | Pain, Procedural |
| D003075 | Coitus |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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