Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia: "ILLUMINANS" Study

Completed

• Conditions: Neurosurgical Intervention
• Interventions: Other: Collection of datas

• Registration Number: NCT03867955
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

The hypothesis of this study is the variation of the decay slope of the pupil diameter is proportional to the depth of the anesthesia.

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-08
• Study Start: 2019-04-01
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Majors patients
• Score American Society of Anesthesiologists (ASA) 1 or 2
• Managed in the operating theater of the University Hospital of Saint-Etienne for a neurosurgical intervention.

Exclusion Criteria

• Single or bilateral eye surgery modifying the possibilities of variation of the pupillary diameter
• Having been asleep under general anesthesia in the 7 days prior to the current surgery
• History of Parkinson's disease, insulin-dependent or non-insulin-dependent diabetes at a dysautonomic stage or chronic alcoholism at a dysautonomous stage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who have a neurosurgical intervention	Collection of datas	Patients who have a neurosurgical intervention will be included. They will have a collection of datas.

Primary Outcome Measures

Name	Time	Method
slope (or rate) of pupil diameter change	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.

Secondary Outcome Measures

Name	Time	Method
latency and the amplitude of pupillary diameter reduction	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™.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France