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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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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.
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:
Patient participation in the study lasts from 1 to 7 days maximum (from preoperative inclusion to hospital discharge).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| orthopaedic surgery | Procedure | orthopaedic surgery of the upper limb under anaesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Jouvenet | Paris | 75016 | France |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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This is an interventional, prospective, randomized, open-label, controlled, single-center study.
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This is a randomized, open-label study.
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| propofol anesthesia | Drug | The initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice. |
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