EUCTR2019-003033-42-ESActive, not recruitingPhase 1
The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery: a multicenter strategy study – EURO RELAX STUDY - EURO RELAX STUDY
INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE0 sites230 target enrollmentStarted: December 20, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 230
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Investigators
Similar Trials
Active, not recruiting
Phase 1
The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery – EURO RELAX STUDYIntra-operative adverse events during laparoscopic surgeryMedDRA version: 21.1Level: PTClassification code 10058468Term: Laparoscopic surgerySystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2021-001503-33-FRCHRU de Nancy184
Completed
Not Applicable
The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery: a multicenter strategy studyanesthesia during laparoscopic surgery i.e. upper gastrointestinal, lower gastrointestinal, urological and gynecologicalanesthesianarcosisNL-OMON52488eids Universitair Medisch Centrum508
Completed
Not Applicable
Compare the effect of progressive muscle relaxation with gentle walking on elderly living in rest-home on life expectancy and general self efficacyelderly living in rest-home._IRCT2016061328433N1Office of research, Yasuj University of Medical Science30
Completed
Not Applicable
Comparison the effect of progressive muscle relaxation program and Benson relaxation on clinical decision making and emotional intelligence of nurses in critical care unitsIRCT20091215002861N16Research Deputy of Shahrekord University of Medical Sciences105
Completed
Not Applicable
Effect of progressive muscle relaxation technique on self-esteem and self-efficacy.Multiple sclerosisIRCT20170411033378N6Hamedan University of Medical Sciences88