The effect of deep relaxation on surgical conditions and morbidity in shoulder surgery
- Conditions
- Subject undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2018-002961-21-BE
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 52
•18 years or older at enrollment
•Subjects who are undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9
•Inability to consent because of mental status
•Open injuries involving the deltoid muscle
•Previous open surgery on the shoulder joint
•American Society of Anesthesiologists (ASA) physical status > II
•Age < 18 or > 75 years old
•Body mass index (BMI) <18,5 or > 35 kg/m²
•Renal insufficiency: glomerular filtration rate < 40 ml/min
• Impaired liver function: hepatic cirrhosis, cholestatic jaundice
• Neuromuscular disease
• Pregnant female subjects
• Breastfeeding female subjects
• Patients receiving medications known to interact with neuromuscular blocking agents
• Allergy to any drug included in the anesthetic protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method