Comparing patient-controlled sedation with anesthesiologist-controlled sedation for orthopedic surgery

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

This study is testing whether patients feel more satisfied with controlling their own sedation or having an anesthesiologist manage it during upper limb orthopedic surgeries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT06451380 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate patient satisfaction between two sedation methods during orthopedic upper limb surgeries: patient-controlled sedation with propofol and anesthesiologist-administered sedation. It is a prospective, randomized, open-label, controlled trial conducted at a single center. Patients aged 18 and over who require additional sedation for their surgery will be randomized into one of two groups to assess the effectiveness and satisfaction of the sedation methods. The study duration for each participant will range from 1 to 7 days, from preoperative inclusion to hospital discharge.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and over who are scheduled for orthopedic surgery of the upper limb requiring additional sedation.

Not a fit: Patients with contraindications to locoregional anesthesia or those unable to understand the study information may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance patient satisfaction and comfort during orthopedic procedures by providing a more personalized sedation approach.

How similar studies have performed: While patient-controlled sedation is less commonly used, similar studies have shown promising results in enhancing patient satisfaction, indicating potential success for this approach.

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.

Where this trial is running

Paris

• Clinique Jouvenet — Paris, France (Recruiting)

Study contacts

• Study coordinator: Philippe MD NGUYEN

Conditions Orthopedic Disorder