Clinical trial
Patient-controlled Sedation With Propofol Versus Anesthesiologist-administered Sedation for Orthopedic Surgery Under Regional Anesthesia : a Prospective Randomized Trial
Name
2024-A00628-39
Description
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Not yet recruiting
Treatment
orthopaedic surgery
orthopaedic surgery of the upper limb under anaesthesia
Arms:
Anesthesiologist-controlled propofol sedation, Patient-controlled propofol sedation
propofol anesthesia
The initial dose of propofol and the refractory period will be determined according to a standardized protocol used in current practice.
Arms:
Anesthesiologist-controlled propofol sedation, Patient-controlled propofol sedation
Size
70
Primary endpoint
patient satisfaction
up to 7 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is an interventional, prospective, randomized, open-label, controlled, single-center study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is a randomized, open-label study.'}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2024-06-11
1 organization
1 product
1 indication
Product
PropofolIndication
Orthopedic Disorder