Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol (ALGISAP 2023)

Pupilometric Evaluation of Nociception in Patients With Orthopedic Impairment Under Procedural Sedation With Propofol in the Context of the Use of the ALGISCAN Device in the Vital Emergency Department in Pasteur 2 Hospital, Nice France

Procedural sedation involves the administration of sedative medications that allow patients to tolerate painful procedures. Procedural sedation has been formally recommended by experts from the French Society of Emergency Medicine (SFMU) since 2010 and procedural sedation using propofol in emergency departments has been recommended by the American College of Emergency Physicians in 2018.

Propofol monotherapy is now widely used in emergency medicine (EM) in France as part of procedural sedation for performing painful procedures, however propofol has no analgesic properties per se .

Pupilometry makes it possible to study the depth of analgesia by evaluating the body's nociceptive response via the ANS by studying the pupil diameter.

This technique would allow the evaluation of the analgesia level in patients sedated by PROPOFOL during the realization of painful procedures. Variations in pupil diameter during painful procedures under procedural sedation in an emergency department will be assesed in this study. Secondly, patients satisfaction following the procedure will also be evaluated by the use of the French version of the "ISAS-F", the Iowa Satisfaction with Anesthesia Scale.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Other: Pupilometric evaluation

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: fanny HAMARD, PH; Phone Number: 0492038581; Email: hamard.f@chu-nice.fr
• Study Contact Backup: Name: laurent Bouchama; Phone Number: 0492038581; Email: bouchama.l@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Nice University Hospital
    • Contact: laurent Bouchama; Phone Number: 0492038581; Email: bouchama.l@chu-nice.fr
    • Contact: Fanny Hamard; Phone Number: 0492038581; Email: hamard.f@chu-nice.fr
    • Principal Investigator: Fanny Hamard
    • Sub-Investigator: laurent Bouchama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted at vital emergency room, consecutive to an orthopedic trauma, for the performance of a painful procedure under procedural sedation with PROPOFOL.

Description

Inclusion Criteria:

• Adult patients
• patient admitted at vital emergency room,
• patient with an orthopedic trauma,
• patient under procedural sedation with PROPOFOL.

Exclusion Criteria:

• Patient's refusal of pupilometry measurement.
• Pre-existing pupil abnormalities.
• history of pathologies with dysautonomic impairment (advanced diabetes, systemic amyloidosis, multiple sclerosis, uncontrolled hypertension, ...).
• Recent administration of Metoclopramide, Droperidol, Clonidine, Dexmedetomidine
• Nitrous oxide prior to procedural sedation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pupilometric evaluation under procedural sedation with propofol	Other: Pupilometric evaluation; Pupilometric evaluation under procedural sedation with propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pupil dilation reflex	Amplitude of pupil dilation reflex (PRD, in % change in pupil diameter)	up to 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupil diameter using the Algiscan device	Pupil diameter using the Algiscan device during the painful procedure.	up to 10 minutes
Pupil diameter variation using the Algiscan	Pupil diameter variation using the Algiscan device during the painful procedure.	up to 10 minutes
Heteroevaluation of the patient's maximal pain	Heteroevaluation of the patient's maximal pain by the doctor, caregiver or nurse using the Algoplus scale (from 0 to 5) during the painful procedure.	up to 10 minutes
Patient's minimal Ramsay score	Patient's minimal Ramsay score (from 0 to 6) during painful procedure	up to 10 minutes
Level of sedation	Level of sedation ("qCON" consciousness index)as continuously measured by the Conox® device	up to 10 minutes
Patient satisfaction	Patient satisfaction as evaluated by the study questionnaire When patients are fully awaked	up to 10 minutes
feasibility of the measurement	Assessment of the feasibility of the measurement by the personnel who carried out the pupilometry measurement.	up to 10 minutes

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Anticipated): March 6, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 23Urgences01_Hamard

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No