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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Neurosurgical Intervention Other: Collection of datas

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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™.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have a neurosurgical intervention will be included.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: David CHARIER, MD (0)477828565 ext +33 David.Charier@chu-st-etienne.fr

Locations
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France
Chu Saint-Etienne Not yet recruiting
Saint-Étienne, France
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: David CHARIER, MD CHU SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03867955     History of Changes
Other Study ID Numbers: IRBN372018/CHUSTE
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
photomotor reflex
depth of anesthesia
AlgiScan™
pupil diameter

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs