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Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol (ALGISAP 2023)

C

Centre Hospitalier Universitaire de Nice

Status

Completed

Conditions

Orthopedic Disorder

Treatments

Other: Pupilometric evaluation

Study type

Observational

Funder types

Other

Identifiers

NCT05750485
23Urgences01_Hamard

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

6 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

fanny HAMARD, PH; Laurent BOUCHAMA

Data sourced from clinicaltrials.gov

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