NCT06451380

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	orthopaedic surgery	orthopaedic surgery of the upper limb under anaesthesia
DRUG	propofol anesthesia	The initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice.

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-01-09
• Completion: 2025-01-09
• First posted: 2024-06-11
• Last updated: 2025-11-24

Locations

1 site across 1 country: France