Orthopedic DisorderPACOSANCT06451380
Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery
A study testing orthopaedic surgery and propofol anesthesia in people with Orthopedic Disorder, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of this study is to compare patient satisfaction with patient-controlled sedation with propofol and anesthesiologist-controlled sedation during orthopedic procedures of the upper limb under locoregional anesthesia. 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?
- orthopaedic surgery and propofol anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2024to 9 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18 and over;
- Patients indicated for orthopedic surgery of the upper limb under anaesthesia requiring additional sedation;
- Ability to use the patient-controlled sedation device;
- Body Mass Index less than 40 kg/m²;
- American Society of Anesthesiologists Class I to III;
- Patient agreeing to study assessments and follow-up visits
- Patient having been informed and agreeing to participate in the study by signing an informed consent form.
Who cannot join
- Contraindications to locoregional anesthesia (allergy, local infection, coagulation disorders);
- Surgery of the upper limb not compatible with locoregional anesthesia (arthroplasty);
- Patient unable to understand study information for linguistic, psychological or cognitive reasons linguistic, psychological or cognitive reasons ;
- Patient pregnant or likely to be pregnant, of childbearing age, without effective contraception or breastfeeding ;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient under legal protection, or deprived of liberty by judicial or administrative decision administrative ;
- Patient not covered by a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery Under Regional Anesthesia : a Prospective Randomized Trial
The purpose of this study is to compare patient satisfaction with patient-controlled sedation with propofol and anesthesiologist-controlled sedation during orthopedic procedures of the upper limb under locoregional anesthesia.
Read the detailed description
This is an interventional, prospective, randomized, open-label, controlled, single-center study designed to evaluate the less commonly used patient-controlled sedation, comparing it with sedation administered by the anesthesiologist in a population of patients indicated for orthopedic upper limb surgery requiring additional sedation.
Once informed consent has been signed, patients will be randomized into one of two study arms in a 1:1 ratio, stratified by age:
- Experimental arm (1) : patient-controlled propofol sedation ;
- Control arm (2) : anesthesiologist-controlled propofol sedation.
Patient participation in the study lasts from 1 to 7 days maximum (from preoperative inclusion to hospital discharge).
- Conditions
- Orthopedic Disorder
- Being tested
- orthopaedic surgery, propofol anesthesia
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthopaedic surgeryProcedure or surgery
orthopaedic surgery of the upper limb under anaesthesia
propofol anesthesiaDrug
The initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice.
| Study group | Role | What they receive |
|---|---|---|
| Patient-controlled propofol sedation | Experimental | Patients in the experimental arm will receive self-controlled sedation using a programmable infusion device, which will deliver boluses of propofol at the patient's request.
The initial dose of propofol, the bolus dose and the refractory period will be determined according to a standardized protocol used in current practice.
Patients will be trained in the use of the device prior to the procedure. An anesthetist will be present to monitor the patient and intervene in the event of complications. Receives: Procedure: orthopaedic surgery; Drug: propofol anesthesia |
| Anesthesiologist-controlled propofol sedation | Active comparator | Patients in the control arm will receive sedation administered and monitored by an anesthetist, who will adjust the dose of propofol according to the patient's needs.
A standardized protocol for propofol administration and dose adjustment criteria will be followed until a mild sedation score is achieved.
The anesthetist will continuously monitor the patient and adjust the sedation accordingly. Receives: Procedure: orthopaedic surgery; Drug: propofol anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Comparison between the 2 groups of patient satisfaction assessed by the total score of the Evaluation of the Experience of Locoregional Anesthesia at the end of the procedure, once the patients had left the recovery room.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start2 Oct 2024
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
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 GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional, prospective, randomized, open-label, controlled, single-center study.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451380
- Sponsor's protocol ID
- 2024-A00628-39
- Acronym
- PACOSA
- Status last verified
- Nov 2025
- First submitted
- 4 Jun 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery Under Regional Anesthesia : a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06451380
- Acronym / sponsor ID
- PACOSA / 2024-A00628-39
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 11 Jun 2024 (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.
The purpose of this study is to compare patient satisfaction with patient-controlled sedation with propofol and anesthesiologist-controlled sedation during orthopedic procedures of the upper limb under locoregional anesthesia.
Detailed description
This is an interventional, prospective, randomized, open-label, controlled, single-center study designed to evaluate the less commonly used patient-controlled sedation, comparing it with sedation administered by the anesthesiologist in a population of patients indicated for orthopedic upper limb surgery requiring additional sedation.
Once informed consent has been signed, patients will be randomized into one of two study arms in a 1:1 ratio, stratified by age:
- Experimental arm (1) : patient-controlled propofol sedation ;
- Control arm (2) : anesthesiologist-controlled propofol sedation.
Patient participation in the study lasts from 1 to 7 days maximum (from preoperative inclusion to hospital discharge).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an interventional, prospective, randomized, open-label, controlled, single-center study.
| Arm | Type | Receives |
|---|---|---|
| Patient-controlled propofol sedation | Experimental | Procedure: orthopaedic surgery, Drug: propofol anesthesiaPatients in the experimental arm will receive self-controlled sedation using a programmable infusion device, which will deliver boluses of propofol at the patient's request. The initial dose of propofol, the bolus dose and the refractory period will be determined according to a standardized protocol used in current practice. Patients will be trained in the use of the device prior to the procedure. An anesthetist will be present to monitor the patient and intervene in the event of complications. |
| Anesthesiologist-controlled propofol sedation | Active comparator | Procedure: orthopaedic surgery, Drug: propofol anesthesiaPatients in the control arm will receive sedation administered and monitored by an anesthetist, who will adjust the dose of propofol according to the patient's needs. A standardized protocol for propofol administration and dose adjustment criteria will be followed until a mild sedation score is achieved. The anesthetist will continuously monitor the patient and adjust the sedation accordingly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18 and over;
- Patients indicated for orthopedic surgery of the upper limb under anaesthesia requiring additional sedation;
- Ability to use the patient-controlled sedation device;
- Body Mass Index less than 40 kg/m²;
- American Society of Anesthesiologists Class I to III;
Key exclusion criteria (7 listed)
- Contraindications to locoregional anesthesia (allergy, local infection, coagulation disorders);
- Surgery of the upper limb not compatible with locoregional anesthesia (arthroplasty);
- Patient unable to understand study information for linguistic, psychological or cognitive reasons linguistic, psychological or cognitive reasons ;
- Patient pregnant or likely to be pregnant, of childbearing age, without effective contraception or breastfeeding ;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
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 |
|---|---|---|
| orthopaedic surgeryorthopaedic surgery of the upper limb under anaesthesia | Procedure or surgery | Anesthesiologist-controlled propofol sedation, Patient-controlled propofol sedation |
| propofol anesthesiaThe initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice. | Drug | Anesthesiologist-controlled propofol sedation, Patient-controlled propofol sedation |
Primary outcome
patient satisfaction
Time frame: up to 7 days
Comparison between the 2 groups of patient satisfaction assessed by the total score of the Evaluation of the Experience of Locoregional Anesthesia at the end of the procedure, once the patients had left the recovery room.
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 24 Nov 2025.
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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?
A study testing orthopaedic surgery and propofol anesthesia in people with Orthopedic Disorder, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 7 inclusion and 7 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 24 Nov 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?
patient satisfaction (time frame: up to 7 days). 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 24 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.