Clinical trial NCT05750485: Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: pupil dilation reflex
timeFrame: up to 10 minutes
Secondary outcomes:
measure: Pupil diameter using the Algiscan device
timeFrame: up to 10 minutes
measure: Pupil diameter variation using the Algiscan
timeFrame: up to 10 minutes
measure: Heteroevaluation of the patient's maximal pain
timeFrame: up to 10 minutes
measure: Patient's minimal Ramsay score
timeFrame: up to 10 minutes
measure: Level of sedation
timeFrame: up to 10 minutes
measure: Patient satisfaction
timeFrame: up to 10 minutes
measure: feasibility of the measurement
timeFrame: up to 10 minutes
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References: