Orthopedic DisorderALGISAP 2023NCT05750485
Pupilometric Evaluation of Patients Under Procedural Sedation With Propofol
An observational study of Orthopedic Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Pupilometric evaluation
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2023to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients
- patient admitted at vital emergency room,
- patient with an orthopedic trauma,
- patient under procedural sedation with PROPOFOL.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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 .
Read more
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
- Being tested
- Pupilometric evaluation
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pupilometric evaluationOther
Pupilometric evaluation under procedural sedation with propofol
| Study group | Role | What they receive |
|---|---|---|
| Pupilometric evaluation under procedural sedation with propofol | Not described Receives: Other: Pupilometric evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupil dilation reflex
Amplitude of pupil dilation reflex (PRD, in % change in pupil diameter)
Measured: up to 10 minutes
Secondary outcomes (7)
Pupil diameter using the Algiscan device
Pupil diameter using the Algiscan device during the painful procedure.
Measured: up to 10 minutes
Pupil diameter variation using the Algiscan
Pupil diameter variation using the Algiscan device during the painful procedure.
Measured: up to 10 minutes
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.
Measured: up to 10 minutes
Patient's minimal Ramsay score
Patient's minimal Ramsay score (from 0 to 6) during painful procedure
Measured: up to 10 minutes
Level of sedation
Level of sedation ("qCON" consciousness index)as continuously measured by the Conox® device
Measured: up to 10 minutes
Patient satisfaction
Patient satisfaction as evaluated by the study questionnaire When patients are fully awaked
Measured: up to 10 minutes
feasibility of the measurement
Assessment of the feasibility of the measurement by the personnel who carried out the pupilometry measurement.
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start6 Mar 2023
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750485
- Sponsor's protocol ID
- 23Urgences01_Hamard
- Acronym
- ALGISAP 2023
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05750485
- Acronym / sponsor ID
- ALGISAP 2023 / 23Urgences01_Hamard
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pupilometric evaluation under procedural sedation with propofol | – | Other: Pupilometric evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adult patients
- patient admitted at vital emergency room,
- patient with an orthopedic trauma,
- patient under procedural sedation with PROPOFOL.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pupilometric evaluationPupilometric evaluation under procedural sedation with propofol | Other | Pupilometric evaluation under procedural sedation with propofol |
Primary outcome
pupil dilation reflex
Time frame: up to 10 minutes
Amplitude of pupil dilation reflex (PRD, in % change in pupil diameter)
7 secondary outcomes
Pupil diameter using the Algiscan device
Time frame: up to 10 minutes
Pupil diameter variation using the Algiscan
Time frame: up to 10 minutes
Heteroevaluation of the patient's maximal pain
Time frame: up to 10 minutes
Patient's minimal Ramsay score
Time frame: up to 10 minutes
Level of sedation
Time frame: up to 10 minutes
Patient satisfaction
Time frame: up to 10 minutes
feasibility of the measurement
Time frame: up to 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupil dilation reflex (time frame: up to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.