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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003033-42-ES

Enrollment

230

Registered

2019-12-20

Start date

2020-01-28

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-operative adverse events during laparoscopic surgery

Interventions

Trade Name: Esmeron Pharmaceutical Form: Injection INN or Proposed INN: ROCURONIUM Other descriptive name: ROCURONIUM BROMIDE Concentrat

Eligibility

Sex/Gender

All

Inclusion 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

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)

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: • Surgical working conditions (L-SRS) • 30 day post-operative complications (Clavien-Dindo) • 30-day post-operative complications according to the Comprehensive Complication Index • 30 day unplanned readmission rates 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): Intra-operative adverse events evaluated with the CLASSIC Score form;Timepoint(s) of evaluation of this end point: during laparoscopic surgery	—

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: • Surgical working conditions (L-SRS) • 30 day post-operative complications (Clavien-Dindo) • 30-day post-operative complications according to the Comprehensive Complication Index • 30 day unplanned readmission rates 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): Intra-operative adverse events evaluated with the CLASSIC Score form;Timepoint(s) of evaluation of this end point: during laparoscopic surgery

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: During the 30 post-operative days.; Secondary end point(s): Study the effect of deep neuromuscular block as compared to standard neuromuscular block on: • Surgical working conditions (L-SRS) • 30 day post-operative complications (Clavien-Dindo) • 30-day post-operative complications according to the Comprehensive Complication Index • 30 day unplanned readmission rates • Quality of recovery at post-operative day 1, 2 and 30 after laparoscopic surgery. o Quality-of-recovery (QoR-40 at postoperative day 1 and 2; Aldrete score at the PACU) o Quality-of-life at postoperative day 30 (SF36)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: During the 30 post-operative days.; Secondary end point(s): Study the effect of deep neuromuscular block as compared to standard neuromuscular block on: • Surgical working conditions (L-SRS) • 30 day post-operative complications (Clavien-Dindo) • 30-day post-operative complications according to the Comprehensive Complication Index • 30 day unplanned readmission rates • Quality of recovery at post-operative day 1, 2 and 30 after laparoscopic surgery. o Quality-of-recovery (QoR-40 at postoperative day 1 and 2; Aldrete score at the PACU) o Quality-of-life at postoperative day 30 (SF36)

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Countries

Spain

Contacts

Public ContactCLINICAL TRIALS INFORMATION

INSTITUTO DE INVESTIGACION SANITARIA LA FE

investigacion_clinica@iislafe.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026