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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monique van Velzen, PhD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université De Lorraine | Nancy | Meurthe-et-Moselle | 54000 | France | ||
| Istituto Nazionale Dei Tumori |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29791482 | Background | 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. | |
| 27936214 |
| Label | URL |
|---|---|
| Link to calculate comprehensive complication index | View source |
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Protocol and SAP will be published before start study. CSR will be reported after article publication in a peer reviewed journal.
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.
To be declared
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Neuromuscular Blockade | Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions |
| FG001 | Deep Neuromuscular Block |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2021 |
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| 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 |
| 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 | 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 | 30 postoperative days |
| Milan |
| 20133 |
| Italy |
| RadboudUMC | Nijmegen | Gelderland | 6525GA | Netherlands |
| LUMC | Leiden | South Holland | 2333ZA | Netherlands |
| Noordwest ziekenhuis groep | Alkmaar | 1815 JD | Netherlands |
| Netherlands Cancer institute | Amsterdam | 1066 CX | Netherlands |
| Canisius Wilhelmina Ziekenhuis | Nijmegen | 6532 SZ | Netherlands |
| Hospital Universitari I Politecnic La Fe | Valencia | 46026 | Spain |
| 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. |
| 24240315 | 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. |
| 25665678 | 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. |
| 28969327 | 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. |
| 28643056 | 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. |
| 15273542 | 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. |
| 34702332 | Derived | 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. |
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
Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Neuromuscular Blockade | Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions |
| BG001 | 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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | Day of surgery |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Day of surgery |
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| Secondary | 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 | Posted | Count of Participants | Participants | 30 postoperative days |
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| Secondary | 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 | Not Posted | 2 postoperative days | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | 30 postoperative days | Participants |
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Neuromuscular Blockade | Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions | 0 | 361 | 24 | 361 | 65 | 361 |
| EG001 | 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 Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count | 0 | 362 | 23 | 362 | 51 | 362 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unplanned readmission | Surgical and medical procedures | Systematic Assessment | Unplanned readmission rate within 30days after surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative nausea vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martijn Boon MD PhD | LUMC | 003171522301 | m.boon@lumc.nl |
| May 27, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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