Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

NCT05750485 | Completed

• 1 other identifier: 23Urgences01_Hamard
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• pupil dilation reflex

  Amplitude of pupil dilation reflex (PRD, in % change in pupil diameter)

  up to 10 minutes

Secondary Outcomes (7)

• Pupil diameter using the Algiscan device

  up to 10 minutes

• Pupil diameter variation using the Algiscan

  up to 10 minutes

• Heteroevaluation of the patient's maximal pain

  up to 10 minutes

• Patient's minimal Ramsay score

  up to 10 minutes

• Level of sedation

  up to 10 minutes

Study Arms (1)

Pupilometric evaluation under procedural sedation with propofol

Other: Pupilometric evaluation

Interventions

Pupilometric evaluation OTHER

Pupilometric evaluation under procedural sedation with propofol

Pupilometric evaluation under procedural sedation with propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients
• patient admitted at vital emergency room,
• patient with an orthopedic trauma,
• patient under procedural sedation with PROPOFOL.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 1, 2023
• Study Start: March 6, 2023
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)