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

Neurosurgical Intervention Clinical Trial

— ILLUMINANS  

Official title:

Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia. Prospective, Monocentric, Observational Compendium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867955
• Other study ID #: IRBN372018/CHUSTE
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurosurgical Intervention

Intervention

Other:
• Collection of datas
Collection of datas by videopupillometer results: pupil diameter and variation of the pupillary diameter.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	slope (or rate) of pupil diameter change	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.	Day 0
Secondary	latency and the amplitude of pupillary diameter reduction	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™.	Day 0