Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

Orthopedic Disorder Clinical Trial

— ALGISAP 2023  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05750485
• Other study ID #: 23Urgences01_Hamard
• Status: Not yet recruiting
• Start date: March 6, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: fanny HAMARD, PH
• Phone: 0492038581
• Email: hamard.f[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Other:
• Pupilometric evaluation
Pupilometric evaluation under procedural sedation with propofol

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pupil dilation reflex	Amplitude of pupil dilation reflex (PRD, in % change in pupil diameter)	up to 10 minutes
Secondary	Pupil diameter using the Algiscan device	Pupil diameter using the Algiscan device during the painful procedure.	up to 10 minutes
Secondary	Pupil diameter variation using the Algiscan	Pupil diameter variation using the Algiscan device during the painful procedure.	up to 10 minutes
Secondary	Heteroevaluation of the patient's maximal pain	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.	up to 10 minutes
Secondary	Patient's minimal Ramsay score	Patient's minimal Ramsay score (from 0 to 6) during painful procedure	up to 10 minutes
Secondary	Level of sedation	Level of sedation ("qCON" consciousness index)as continuously measured by the Conox® device	up to 10 minutes
Secondary	Patient satisfaction	Patient satisfaction as evaluated by the study questionnaire When patients are fully awaked	up to 10 minutes
Secondary	feasibility of the measurement	Assessment of the feasibility of the measurement by the personnel who carried out the pupilometry measurement.	up to 10 minutes