Neurosurgical InterventionILLUMINANSNCT03867955
Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia: "ILLUMINANS" Study
An observational study of Neurosurgical Intervention, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurosurgical Intervention
- What is being tested?
- Collection of datas
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 15 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have a neurosurgical intervention will be included.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia. Prospective, Monocentric, Observational Compendium
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.
Read more
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.
Read the 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.
- Conditions
- Neurosurgical Intervention
- Being tested
- Collection of datas
- Keywords
- photomotor reflex, depth of anesthesia, AlgiScan™, pupil diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of datasOther
Collection of datas by videopupillometer results: pupil diameter and variation of the pupillary diameter.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have a neurosurgical intervention | Patients who have a neurosurgical intervention will be included. They will have a collection of datas. Receives: Other: Collection of datas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (1)
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™.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start1 Apr 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosurgical InterventionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David CHARIER, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867955
- Sponsor's protocol ID
- IRBN372018/CHUSTE
- Acronym
- ILLUMINANS
- Status last verified
- Aug 2023
- First submitted
- 6 Mar 2019
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia. Prospective, Monocentric, Observational Compendium
- ClinicalTrials.gov ID
- NCT03867955
- Acronym / sponsor ID
- ILLUMINANS / IRBN372018/CHUSTE
- Conditions
- Neurosurgical Intervention
- Keywords
- photomotor reflex, depth of anesthesia, AlgiScan™, pupil diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have a neurosurgical intervention | – | Other: Collection of datasPatients who have a neurosurgical intervention will be included. They will have a collection of datas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a neurosurgical intervention will be included.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of datasCollection of datas by videopupillometer results: pupil diameter and variation of the pupillary diameter. | Other | Patients who have a neurosurgical intervention |
Primary outcome
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.
1 secondary outcome
latency and the amplitude of pupillary diameter reduction
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Neurosurgical Intervention
RecruitingObservational study
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
RecruitingEarly Phase 1
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Meningioma, Glioblastoma
RecruitingPhase 1/2
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
Brain Tumor
Not yet recruiting
Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury
Moderate-to-Severe Traumatic Brain Injury
RecruitingPhase 1/2
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
Malignant Brain Neoplasm, Malignant Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David CHARIER, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosurgical Intervention, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
slope (or rate) of pupil diameter change (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.