Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety (EURORELAX)

May 27, 2025 updated by: Martijn Boon, Leiden University Medical Center

The Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety During Laparoscopic Surgery: a Multicenter Strategy Study

Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular block (NMB) improves the surgical working conditions over a moderate NMB and effectively precludes sudden deterioration of the surgical field. However, whether the improvement of surgical working conditions translates into less intra- and postoperative complications remains uncertain. Small prospective or retrospective studies shown an decrease of the incidence of intraoperative adverse events and postoperative complications after a deep NMB. There is a need to confirm these outcome data prospectively, in a large number of patients and clinics and during a variety of surgical procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Muscle relaxants are routinely applied during anesthesia to facilitate endotracheal intubation and to improve surgical working conditions. Several investigations have shown that a deep neuromuscular block (NMB) (post tetanic count (PTC) 1-2 twitches) improves the surgical working conditions over a moderate NMB (TOF count 1-3 twitches) and effectively precludes sudden deterioration of the surgical field. However, whether the improvement of surgical working conditions translates into less intra- and postoperative complications remains uncertain. A recent retrospective analysis of neuromuscular management during laparoscopic retroperitoneal surgery showed a reduced rate of unplanned 30 day readmissions when a deep NMB over a moderate NMB was applied (3.8% vs. 12.7%).In addition, a pooled analysis of 4 randomized controlled trials comparing different levels of intra-abdominal pressure and neuromuscular blockade during laparoscopic donor nephrectomy, showed a significant reduction in the incidence of intra-operative surgical complications from 12.6% with moderate NMB to 4.8% with deep NMB.

These previous observations were made in small prospective or retrospective studies. There is a need to confirm these outcome data prospectively, in a larger prospective trial for a variety of surgical procedures. We therefore propose a multi-center, randomized controlled trial, to study the effect of a deep NMB (PTC 1-2 twitches) versus standard NMB (single induction dose rocuronium) in a variety of laparoscopic surgical procedures on the incidence of intraoperative adverse events and postoperative outcome data.

In this 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 is evaluated.

Study Type

Interventional

Enrollment (Actual)

731

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54000
        • Université de Lorraine
  • Italy
      • Milano, Italy, 20133
        • Istituto Nazionale dei Tumori
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Noordwest Ziekenhuis Groep
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius Wilhelmina Ziekenhuis
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboudumc
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333ZA
        • LUMC
  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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 (merican society of anesthesiologists) class I-III
  • > 18 years of age
  • Ability to give oral and written informed consent

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 mentioned in paragraph 5.2
  • 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 Glomerular Filtration Rate <30 ml/min)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard neuromuscular blockade
Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions
Experimental: Deep neuromuscular block
Subjects will receive high dose rocuronium induction dose followed by continuous rocuronium administration, to achieve a depth of neuromuscular block of 1-2 twitches post tetanic count
Other: Deep neuromuscular block
Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
Other Names:
  • High dose rocuronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Classic Score>1
Time Frame: Day of surgery

The incidence of symptomatic intra-operative adverse events requiring intervention or treatment (ClassIntra®grade >1) during laparoscopic surgery in the standard of care versus the deep NMB group, as scored by the attending surgeon and anesthesiologist at the end of every procedure. A recent update of the ClassIntra®grade also involved intraoperative adverse events related to anesthesia [Gawria et al 2023]. This study will use both the original classic scoring, as well as an adapted version of the updated classic scoring system.

The Classic score; classification of intraoperative complications, is a 6 point scale ranging from no complications (0) to fatal complications (5).
Day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
L-SRS (Leiden Surgical Rating Scale)
Time Frame: Day of surgery
To study the effect of deep neuromuscular block compared to standard neuromuscular block on peroperative surgical working conditions following the Leiden Surgical Rating scale (a 5 point scale, ranging from poor (1) to excellent (5) surgical conditions.
Day of surgery
30 Day Post-operative Complications
Time Frame: 30 postoperative days
To study the effect of deep neuromuscular block compared to standard neuromuscular block on 30 day post-operative complications according the Clavien-Dindo score en Comprehensive Complication Index and unplanned readmissions
30 postoperative days
Quality of Recovery (QoR)
Time Frame: 2 postoperative days
To study the effect of deep neuromuscular block compared to standard neuromuscular block on Quality of Recovery at post-operative day 1, 2 according to the Quality of Recovery-40
2 postoperative days
Quality of Life (QoL)
Time Frame: 30 postoperative days
To study the effect of deep neuromuscular block compared to standard neuromuscular block on Quality of life at post-operative day 30 Short Form-36
30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Monique van Velzen, PhD, LUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2020

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P19.065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol and SAP will be published before start study. CSR will be reported after article publication in a peer reviewed journal.

IPD Sharing Time Frame

Protocol and Statistical Analysis Plan will be published before start study. Clinical Study Report will be reported after article publication in a peer reviewed journal.

IPD Sharing Access Criteria

To be declared

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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