Neuromuscular Blockade Clinical Trial
— EURORELAXOfficial title:
The Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety During Laparoscopic Surgery: a Multicenter Strategy Study
NCT number | NCT04124757 |
Other study ID # | P19.065 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 11, 2020 |
Est. completion date | June 1, 2024 |
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.
Status | Recruiting |
Enrollment | 922 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | Université De Lorraine | Nancy | Meurthe-et-Moselle |
Italy | Istituto Nazionale Dei Tumori | Milano | |
Netherlands | Noordwest ziekenhuis groep | Alkmaar | |
Netherlands | Netherlands Cancer institute | Amsterdam | |
Netherlands | LUMC | Leiden | Zuid-Holland |
Netherlands | Canisius Wilhelmina Ziekenhuis | Nijmegen | |
Netherlands | RadboudUMC | Nijmegen | Gelderland |
Spain | Hospital Universitari I Politecnic La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Merck Sharp & Dohme LLC |
France, Italy, Netherlands, Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Classic score | The incidence of symptomatic intra-operative adverse events requiring intervention or treatment (ClassIntra®grade = 2) 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 | 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 | |
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 | 30 postoperative days | |
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 | 2 postoperative days | |
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 | 30 postoperative days |
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