The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery: a multicenter strategy study – EURO RELAX STUDY

INTERVENTION: 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 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: 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 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: 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 Primary end point(s): Incidence of intra‐operative adverse events (CLASSIC grade = 2) between deep and standard NMB 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) ; ; Timepoint(s) of evaluation of this end point: During laparoscopic surgery SECONDARY OUTCOME: 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 Inde X((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 INCLUSION CRITERIA: 1/ Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: ‘MAJOR’, ‘MAJOR PLUS’ or ‘COMPLE XMAJOR’ 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