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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03867955

Acronym

ILLUMINANS

Enrollment

Registered

2019-03-08

Start date

2019-04-01

Completion date

2020-03-15

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurosurgical Intervention

Keywords

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

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.

Interventions

OTHERCollection of datas

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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™.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026