Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-06

Study Completion Date

2023-05-31

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.

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Detailed Description

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Conditions

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Orthopedic Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pupilometric evaluation under procedural sedation with propofol

Pupilometric evaluation

Intervention Type OTHER

Pupilometric evaluation under procedural sedation with propofol

Interventions

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Pupilometric evaluation

Pupilometric evaluation under procedural sedation with propofol

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No