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

Orthopedic Disorder Clinical Trial

— PACOSA  

Official title:

Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery Under Regional Anesthesia : a Prospective Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451380
• Other study ID #: 2024-A00628-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Philippe MD NGUYEN
• Phone: 686408284
• Email: philippe.nguyen.pro[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Jouvenet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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