Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia: "ILLUMINANS" Study (ILLUMINANS)
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|ClinicalTrials.gov Identifier: NCT03867955|
Recruitment Status : Not yet recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Pupillary diameter monitoring is currently used routinely for assessment of the nociception / antinociception balance during surgery.
Pupillary diameter decreases reflexively in response to light flash, called photomotor reflex. The photomotor reflex is described by the latency between the light flash and the beginning of the decay expressed in milliseconds, the slope or decay rate expressed in millimeters per second, and the percentage of variation, corresponding to the ratio between the basal pupil diameter and the minimum diameter reached during the light stimulation.
The AlgiScan™ videopupillometer used includes a device for producing a flash light, designed for this purpose.
It has recently been shown that the slope (or rate) of pupillary diameter decrease during a light flash varies during anesthesia, independently of any nociceptive stimulus.
|Condition or disease||Intervention/treatment|
|Neurosurgical Intervention||Other: Collection of datas|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia: "ILLUMINANS" Study. Prospective, Monocentric, Observational Compendium|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Patients who have a neurosurgical intervention
Patients who have a neurosurgical intervention will be included. They will have a collection of datas.
Other: Collection of datas
Collection of datas by videopupillometer results: pupil diameter and variation of the pupillary diameter.
- slope (or rate) of pupil diameter change [ Time Frame: Day 0 ]To compare the slope (or rate) of pupil diameter change obtained during a standardized 320 Lux light flash and the depth of anesthesia evaluated by the Bispectral Index (BIS™) at different levels of depth of anesthesia.
- latency and the amplitude of pupillary diameter reduction [ Time Frame: Day 0 ]Correlation between the latency and the amplitude of pupillary diameter reduction obtained during a standardized 320 Lux light flash between the basic pupillary diameter, Pupillary Unrest in Ambient Light (PUAL) and between eyeball movements, and depth of anesthesia as assessed by BIS™.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867955
|Contact: David CHARIER, MD||(0)477828565 ext +33||David.Charier@chu-st-etienne.fr|
|Chu Saint-Etienne||Not yet recruiting|
|Contact: David CHARIER, MD (0)477828565 ext +33 David.Charier@chu-st-etienne.fr|
|Principal Investigator: David CHARIER, MD|
|Sub-Investigator: Serge MOLLIEX, PhD|
|Sub-Investigator: Patrick GROMOLARD, MD|
|Sub-Investigator: Clément MAGAND, MD|
|Sub-Investigator: Pierre LAMBERT, MD|
|Sub-Investigator: René ALLARY, MD|
|Principal Investigator:||David CHARIER, MD||CHU SAINT-ETIENNE|