The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery – EURO RELAX STUDY
- Conditions
- Intra-operative adverse events during laparoscopic surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2019-003033-42-ES
- Lead Sponsor
- INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 230
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
• Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: ‘MAJOR’, ‘MAJOR PLUS’ or ‘COMPLEX MAJOR’
• ASA class I-III
• > 18 years of age
• Ability to give oral and written informed consent
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 230
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Low or intermediate complexity laparoscopic procedures (BUPA ‘SIMPLE’ or ‘INTER’)
• Known or suspected neuromuscular disorders impairing neuromuscular function
• Allergies to muscle relaxants, anesthetics or narcotics
• A (family) history of malignant hyperthermia
• Women who are or may be pregnant or are currently breast feeding
• Chronic use of any type of opioid or psychotropic drug
• Use of NSAID’s shorter than 5 days before surgery
• Indication for rapid sequence induction
• Contra-indication for sugammadex use (e.g. known sugammadex allergy or GFR<30 ml/min)
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