Intra-operative adverse events during laparoscopic surgery MedDRA version: 21.1 Level: PT Classification code 10058468 Term: Laparoscopic surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: ESMERON
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROCURONIUM
CAS Number: 119302-91-9
Current Sponsor code: roucuronium
Other descriptive name: ROCURONIUM
Concentrati
Sponsors
CHRU de Nancy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1/ Surgical working conditions (L-SRS) 2/ 30-day post-operative complications (Clavien-Dindo) 3/ 30-day post-operative complications according to the Comprehensive Complication Index ((https://www.assessurgery.com/) 4/ 30-day unplanned readmission rates 5/Quality of recovery at post-operative day 1, 2 and 30 after laparoscopic surgery: -Quality-of-recovery (QoR-40 at postoperative day 1 and 2; Aldrete score at the PACU) -Quality-of-life at postoperative day 30 (SF36) ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ Surgical working conditions (L-SRS) 2/ 30-day post-operative complications (Clavien-Dindo grade = 2) 3/ 30-day post-operative complications according to the Comprehensive Complication Index ((https://www.assessurgery.com/) 4/ 30-day unplanned re-admissions 5/ Quality-of-recovery at the PACU: Aldrete score at post-operative day 1 and day 2 : Quality-of-recovery (QoR-40) at post-operative day 30 : Quality-of-life (SF36);Timepoint(s) of evaluation of this end point: 1/During laparoscopic surgery 2/ during the 30 post-operative days 3/ during the 30 post-operative days 4/ during the 30 post-operative days 5/ at the PACU: Aldrete score at post-operative day 1 and day 2 : Quality-of-recovery during the 30 post-operative days : Quality-of-life | — |
Countries
France
Contacts
Public ContactDirection de la Recherche Clinique
CHRU de Nancy
Outcome results
None listed