NCT05750485

Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthopedic Disorder

Interventions

Type	Name	Description
OTHER	Pupilometric evaluation	Pupilometric evaluation under procedural sedation with propofol

Timeline

• Start date: 2023-03-06
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2023-03-01
• Last updated: 2025-04-08

Locations

1 site across 1 country: France