Neuromuscular BlockadeEURORELAXNCT04124757
Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety
A study testing Deep neuromuscular block in people with Neuromuscular Blockade and Rocuronium, run by Leiden University Medical Center at 8 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Rocuronium, Anesthetics
- What is being tested?
- Deep neuromuscular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 11 Feb 2020to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Netherlands5 sites
Noordwest ziekenhuis groep
Alkmaar, 1815 JD
Netherlands Cancer institute
Amsterdam, 1066 CX
LUMC
Leiden, South Holland, 2333ZA
RadboudUMC
Nijmegen, Gelderland, 6525GA
Canisius Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuromuscular Blockade, Rocuronium, Anesthetics, Anesthesia Complication, Neuromuscular Blocking Agents, Surgery--Complications
- Being tested
- Deep neuromuscular block
- Keywords
- Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular blockOther
Also called High dose rocuronium
Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Deep neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day of surgery
Secondary outcomes (4)
L-SRS (Leiden Surgical Rating Scale)
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.
Measured: Day of surgery
30 Day Post-operative Complications
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
Measured: 30 postoperative days
Quality of Recovery (QoR)
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
Measured: 2 postoperative days
Quality of Life (QoL)
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
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start11 Feb 2020
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Martijn Boon, Leiden University Medical Center
- Investigators
- Monique van Velzen, PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124757
- Sponsor's protocol ID
- P19.065
- Acronym
- EURORELAX
- Status last verified
- May 2025
- First submitted
- 9 Oct 2019
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and SAP will be published before start study. CSR will be reported after article publication in a peer reviewed journal.
Publications
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.
PubMed 29791482Torensma 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.
PubMed 27936214Martini 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.
PubMed 24240315Rosenthal 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.
PubMed 25665678Madsen 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.
PubMed 28969327Ozdemir-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.
PubMed 28643056Dindo 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.
PubMed 15273542Honing 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.
PubMed 34702332
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety During Laparoscopic Surgery: a Multicenter Strategy Study
- ClinicalTrials.gov ID
- NCT04124757
- Acronym / sponsor ID
- EURORELAX / P19.065
- Conditions
- Neuromuscular Blockade, Rocuronium, Anesthetics, Anesthesia Complication, Neuromuscular Blocking Agents, Surgery--Complications
- Keywords
- Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Deep neuromuscular blockSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep neuromuscular blockAlso: High dose rocuroniumDeep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count | Other | Deep neuromuscular block |
Primary outcome
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).
4 secondary outcomes
L-SRS (Leiden Surgical Rating Scale)
Time frame: Day of surgery
30 Day Post-operative Complications
Time frame: 30 postoperative days
Quality of Recovery (QoR)
Time frame: 2 postoperative days
Quality of Life (QoL)
Time frame: 30 postoperative days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29791482Boon 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.
- Background: PubMed 27936214Torensma 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.
- Background: PubMed 24240315Martini 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.
- Background: PubMed 25665678Rosenthal 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.
- Background: PubMed 28969327Madsen 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.
- Background: PubMed 28643056Ozdemir-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.
- Background: PubMed 15273542Dindo 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.
- Derived from this study: PubMed 34702332Honing 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.
- Link to calculate comprehensive complication indexLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Protocol and SAP will be published before start study. CSR will be reported after article publication in a peer reviewed journal.
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Muscle Relaxants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monique van Velzen, PhD principal investigator
LUMC
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep neuromuscular block in people with Neuromuscular Blockade and Rocuronium, run by Leiden University Medical Center at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, France, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classic Score>1 (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124757, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.