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Completed

NCT Number: NCT05750485

Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol

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.

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Key information

Conditions

Orthopedic Disorder Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pupilometric evaluation

Other

Pupilometric evaluation under procedural sedation with propofol

Primary outcomes

  1. pupil dilation reflex

    Time frame: up to 10 minutes

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

Secondary outcomes

  1. Pupil diameter using the Algiscan device

    Time frame: up to 10 minutes

    Pupil diameter using the Algiscan device during the painful procedure.

  2. Pupil diameter variation using the Algiscan

    Time frame: up to 10 minutes

    Pupil diameter variation using the Algiscan device during the painful procedure.

  3. Heteroevaluation of the patient's maximal pain

    Time frame: 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.

  4. Patient's minimal Ramsay score

    Time frame: up to 10 minutes

    Patient's minimal Ramsay score (from 0 to 6) during painful procedure

  5. Level of sedation

    Time frame: up to 10 minutes

    Level of sedation ("qCON" consciousness index)as continuously measured by the Conox® device

  6. Patient satisfaction

    Time frame: up to 10 minutes

    Patient satisfaction as evaluated by the study questionnaire When patients are fully awaked

  7. feasibility of the measurement

    Time frame: up to 10 minutes

    Assessment of the feasibility of the measurement by the personnel who carried out the pupilometry measurement.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Acronym: ALGISAP 2023

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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