Orthopedic Disorder
Conditions
Brief 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.
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).
Interventions
PROCEDUREorthopaedic surgery
orthopaedic surgery of the upper limb under anaesthesia
The initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice.
Sponsors
Euraxi Pharma
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is a randomized, open-label study.
Intervention model description
This is an interventional, prospective, randomized, open-label, controlled, single-center study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | 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. |
Countries
France
Outcome results
None listed