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

NCT ID: NCT06451380

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-02
• Study Completion Date: 2025-01-09

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).

Conditions

Orthopedic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient-controlled propofol sedation

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.

Group Type: EXPERIMENTAL

orthopaedic surgery

Intervention Type: PROCEDURE

orthopaedic surgery of the upper limb under anaesthesia

propofol anesthesia

Intervention Type: DRUG

The initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice.

Anesthesiologist-controlled propofol sedation

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.

Group Type: ACTIVE_COMPARATOR

orthopaedic surgery

Intervention Type: PROCEDURE

orthopaedic surgery of the upper limb under anaesthesia

propofol anesthesia

Intervention Type: DRUG

The initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice.

Interventions

orthopaedic surgery

orthopaedic surgery of the upper limb under anaesthesia

Intervention Type: PROCEDURE

propofol anesthesia

The initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Jouvenet

Paris, , France

Countries

France

Other Identifiers

2024-A00628-39

Identifier Type: -

Identifier Source: org_study_id