Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Orthopedic Disorder

Intervention / Treatment
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* Other: Pupilometric evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pupilometric evaluation under procedural sedation with propofol<br> | Other: Pupilometric evaluation<br>* Pupilometric evaluation under procedural sedation with propofol<br>|

What is the study measuring?
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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 |