Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

Completed

• Conditions: Orthopedic Disorder
• Interventions: Other: Pupilometric evaluation

• Registration Number: NCT05750485
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-01
• Study Start: 2023-03-06
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pupilometric evaluation under procedural sedation with propofol	Pupilometric evaluation	-

Primary Outcome Measures

Name	Time	Method
pupil dilation reflex	up to 10 minutes	Amplitude of pupil dilation reflex (PRD, in % change in pupil diameter)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France