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

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Jun 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to help patients feel relaxed during orthopedic surgery on the upper limb, which includes surgeries like fixing broken bones or repairing tendons. The study compares a method where patients can control their own sedation using a special device with the traditional method where an anesthesiologist administers sedation. The researchers want to see which method makes patients feel more comfortable and satisfied during their procedure.

To participate in this trial, you need to be at least 18 years old and be scheduled for upper limb orthopedic surgery that requires extra sedation. You should also be able to use the patient-controlled device, have a body mass index (BMI) under 40, and be in good overall health. If you join the study, you will have the chance to control your sedation during the surgery, and you’ll be monitored closely. It’s important to know that if you are pregnant, have certain health conditions, or are involved in another clinical trial, you may not be eligible to participate. If you're interested, you would need to give your consent to take part in the study.

Gender

ALL

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.