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

NCT03867955 | Completed

• 1 other identifier: IRBN372018/CHUSTE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurosurgical Intervention

Keywords

photomotor reflex; depth of anesthesia; AlgiScan™; pupil diameter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• latency and the amplitude of pupillary diameter reduction

  Day 0

Study Arms (1)

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

Interventions

Collection of datas OTHER

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

Patients who have a neurosurgical intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have a neurosurgical intervention will be included.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

Study Officials

• David CHARIER, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 8, 2019
• Study Start: April 1, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)