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

NCT04124757 | Completed Results

• 1 other identifier: P19.065
• Study Type: interventional
• Target: 731
• Locations: 4 countries
• Sites: 8

Brief Summary

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.

Conditions

Neuromuscular Blockade; Rocuronium; Anesthetics; Anesthesia Complication; Neuromuscular Blocking Agents; Surgery--Complications

Keywords

Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Classic Score>1

  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 Outcomes (4)

• L-SRS (Leiden Surgical Rating Scale)

  Day of surgery

• 30 Day Post-operative Complications

  30 postoperative days

• Quality of Recovery (QoR)

  2 postoperative days

• Quality of Life (QoL)

  30 postoperative days

Study Arms (2)

Standard neuromuscular blockade

NO INTERVENTION

Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions

Deep neuromuscular block

EXPERIMENTAL

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

Interventions

Deep neuromuscular block OTHER

Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count

Also known as: High dose rocuronium

Deep neuromuscular block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (8)

Université De Lorraine

Nancy, Meurthe-et-Moselle, 54000, France

Location

Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

RadboudUMC

Nijmegen, Gelderland, 6525GA, Netherlands

Location

LUMC

Leiden, South Holland, 2333ZA, Netherlands

Location

Noordwest ziekenhuis groep

Alkmaar, 1815 JD, Netherlands

Location

Netherlands Cancer institute

Amsterdam, 1066 CX, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, 6532 SZ, Netherlands

Location

Hospital Universitari I Politecnic La Fe

Valencia, 46026, Spain

Location

Related Publications (8)

• Boon M, Martini C, Yang HK, Sen SS, Bevers R, Warle M, Aarts L, Niesters M, Dahan A. Impact of high- versus low-dose neuromuscular blocking agent administration on unplanned 30-day readmission rates in retroperitoneal laparoscopic surgery. PLoS One. 2018 May 23;13(5):e0197036. doi: 10.1371/journal.pone.0197036. eCollection 2018.

  PMID: 29791482 BACKGROUND

• Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.

  PMID: 27936214 BACKGROUND

• Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

  PMID: 24240315 BACKGROUND

• Rosenthal R, Hoffmann H, Clavien PA, Bucher HC, Dell-Kuster S. Definition and Classification of Intraoperative Complications (CLASSIC): Delphi Study and Pilot Evaluation. World J Surg. 2015 Jul;39(7):1663-71. doi: 10.1007/s00268-015-3003-y.

  PMID: 25665678 BACKGROUND

• Madsen MV, Scheppan S, Mork E, Kissmeyer P, Rosenberg J, Gatke MR. Influence of deep neuromuscular block on the surgeons assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex. Br J Anaesth. 2017 Sep 1;119(3):435-442. doi: 10.1093/bja/aex241.

  PMID: 28969327 BACKGROUND

• Ozdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, Dam RE, Huurman VA, Lam D, d'Ancona FC, Dahan A, Warle MC. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018 Jan;32(1):245-251. doi: 10.1007/s00464-017-5670-2. Epub 2017 Jun 22.

  PMID: 28643056 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Honing M, Reijnders-Boerboom G, Dell-Kuster S, van Velzen M, Martini C, Valenza F, Proto P, Cambronero OD, Broens S, Panhuizen I, Roozekrans M, Fuchs-Buder T, Boon M, Dahan A, Warle M. The impact of deep versus standard neuromuscular block on intraoperative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial - EURO-RELAX TRIAL. Trials. 2021 Oct 26;22(1):744. doi: 10.1186/s13063-021-05638-2.

  PMID: 34702332 DERIVED

Related Links

• Link to calculate comprehensive complication index

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Martijn Boon MD PhD
• Organization: LUMC

m.boon@lumc.nl

003171522301

Study Officials

• Monique van Velzen, PhD

  LUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: February 11, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: To be declared

Locations

FR (1); NL (5); ES (1); IT (1)