Clinical trial NCT06451380: Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery
Official title: Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery Under Regional Anesthesia : a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-06-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an interventional, prospective, randomized, open-label, controlled, single-center study.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: patient satisfaction
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Jouvenet
Study officials:
References: