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 surgeryMedDRA version: 21.1Level: PTClassification code 10058468Term: Laparoscopic surgerySystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2021-001503-33-FR
- Lead Sponsor
- CHRU de Nancy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 184
1/ Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: ‘MAJOR’, ‘MAJOR PLUS’ or ‘COMPLEX MAJOR’
2/ ASA class I-III
3/ > 18 years of age
4/ 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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
1/ Low or intermediate complexity laparoscopic procedures (BUPA ‘SIMPLE’ or ‘INTER’)
2/ Known or suspected neuromuscular disorders impairing neuromuscular function
3/ Allergies to muscle relaxants, anesthetics or narcotics mentioned in paragraph 7
4/ A (family) history of malignant hyperthermia
5/ Women who are or may be pregnant or are currently breast feeding
6/ Chronic use of any type of opioid or psychotropic drug
7/ Use of NSAID’s shorter than 5 days before surgery
8/ Indication for rapid sequence induction
9/ Contra-indication for sugammadex use (e.g. known sugammadex allergy or GFR<30 ml/min)
10/ Persons deprived of liberty for judicial or administrative decision
11/ Persons in health or social institutions for another reason than research
12/ Minors (non emancipated)
13/ Adult persons under legal protection (any form of public guardianship)
14/ Persons incapable of giving consent and not under legal protection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the effect of deep neuromuscular block compared to standard neuromuscular block on intra-operative adverse events during laparoscopic surgery using the CLASSIC score system;Secondary Objective: To study the effect of deep neuromuscular block as compared to standard neuromuscular block on: <br>1/ Surgical working conditions (L-SRS) <br>2/ 30-day post-operative complications (Clavien-Dindo) <br>3/ 30-day post-operative complications according to the Comprehensive Complication Index ((https://www.assessurgery.com/) <br>4/ 30-day unplanned readmission rates <br>5/Quality of recovery at post-operative day 1, 2 and 30 after laparoscopic surgery: <br> -Quality-of-recovery (QoR-40 at postoperative day 1 and 2; Aldrete score at the PACU) <br> -Quality-of-life at postoperative day 30 (SF36) <br><br>;Primary end point(s): Incidence of intra-operative adverse events (CLASSIC grade = 2) between deep and standard NMB;Timepoint(s) of evaluation of this end point: During laparoscopic surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1/ Surgical working conditions (L-SRS) <br>2/ 30-day post-operative complications (Clavien-Dindo grade = 2)<br>3/ 30-day post-operative complications according to the Comprehensive Complication Index ((https://www.assessurgery.com/) <br>4/ 30-day unplanned re-admissions<br>5/ Quality-of-recovery<br>at the PACU: Aldrete score<br>at post-operative day 1 and day 2 : Quality-of-recovery (QoR-40) <br>at post-operative day 30 : Quality-of-life (SF36);Timepoint(s) of evaluation of this end point: 1/During laparoscopic surgery<br>2/ during the 30 post-operative days <br>3/ during the 30 post-operative days <br>4/ during the 30 post-operative days<br>5/ <br>at the PACU: Aldrete score<br>at post-operative day 1 and day 2 : Quality-of-recovery <br>during the 30 post-operative days : Quality-of-life