Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery

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.

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).

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.