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Clinical Trials/NCT03867955
NCT03867955
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country30 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurosurgical Intervention
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
30
Locations
1
Primary Endpoint
slope (or rate) of pupil diameter change
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
March 15, 2020
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • latency and the amplitude of pupillary diameter reduction(Day 0)

Study Sites (1)

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