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

NCT06451380 | Completed

• 1 other identifier: 2024-A00628-39
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Procedure: orthopaedic surgery; Drug: propofol anesthesia

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.

Procedure: orthopaedic surgery; Drug: propofol anesthesia

Interventions

orthopaedic surgery PROCEDURE

orthopaedic surgery of the upper limb under anaesthesia

Anesthesiologist-controlled propofol sedation; Patient-controlled propofol sedation

propofol anesthesia 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; Patient-controlled propofol sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under legal protection, or deprived of liberty by judicial or administrative decision administrative ;
• Patient not covered by a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique Jouvenet

Paris, 75016, France

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a randomized, open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an interventional, prospective, randomized, open-label, controlled, single-center study.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: October 2, 2024
• Primary Completion: January 9, 2025
• Study Completion: January 9, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)