Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
Study NCT ID:
NCT04124757
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2019-10-09
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety
Sponsor:
Organization:
Raw JSON
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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.\n\nThe Classic score; classification of intraoperative complications, is a 6 point scale ranging from no complications (0) to fatal complications (5).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'L-SRS (Leiden Surgical Rating Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Neuromuscular Blockade', 'description': 'Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Block', 'description': '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 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Neuromuscular Blockade', 'description': 'Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Block', 'description': '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\n\nDeep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 postoperative days', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Recovery (QoR)', 'timeFrame': '2 postoperative days', 'description': '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', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL)', 'timeFrame': '30 postoperative days', 'description': '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', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Neuromuscular Blockade', 'description': 'Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions'}, {'id': 'FG001', 'title': 'Deep Neuromuscular Block', 'description': '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\n\nDeep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '367'}, {'groupId': 'FG001', 'numSubjects': '364'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '363'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'BG000'}, {'value': '361', 'groupId': 'BG001'}, {'value': '723', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Neuromuscular Blockade', 'description': 'Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions'}, {'id': 'BG001', 'title': 'Deep Neuromuscular Block', 'description': '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\n\nDeep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '434', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '362', 'groupId': 'BG000'}, {'value': '361', 'groupId': 'BG001'}, {'value': '723', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-29', 'size': 655781, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-27T10:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 731}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2019-10-09', 'resultsFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2019-10-10', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-27', 'studyFirstPostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Classic Score>1', 'timeFrame': 'Day of surgery', 'description': '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.\n\nThe Classic score; classification of intraoperative complications, is a 6 point scale ranging from no complications (0) to fatal complications (5).'}], 'secondaryOutcomes': [{'measure': 'L-SRS (Leiden Surgical Rating Scale)', 'timeFrame': 'Day of surgery', 'description': '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.'}, {'measure': '30 Day Post-operative Complications', 'timeFrame': '30 postoperative days', 'description': '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'}, {'measure': 'Quality of Recovery (QoR)', 'timeFrame': '2 postoperative days', 'description': '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'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': '30 postoperative days', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopy'], 'conditions': ['Neuromuscular Blockade', 'Rocuronium', 'Anesthetics', 'Anesthesia Complication', 'Neuromuscular Blocking Agents', 'Surgery--Complications']}, 'referencesModule': {'references': [{'pmid': '29791482', 'type': 'BACKGROUND', 'citation': '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': '27936214', 'type': 'BACKGROUND', '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."}, {'pmid': '24240315', 'type': 'BACKGROUND', '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.'}, {'pmid': '25665678', 'type': 'BACKGROUND', '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.'}, {'pmid': '28969327', 'type': 'BACKGROUND', '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.'}, {'pmid': '28643056', 'type': 'BACKGROUND', '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."}, {'pmid': '15273542', 'type': 'BACKGROUND', '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.'}, {'pmid': '34702332', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.assessurgery.com/', 'label': 'Link to calculate comprehensive complication index'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThese 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients scheduled for elective laparoscopic procedure with a complexity according to the BUPA classification for case complexity: 'MAJOR', 'MAJOR Plus or 'COMPLEX MAJOR'\n* ASA (merican society of anesthesiologists) class I-III\n* \\> 18 years of age\n* Ability to give oral and written informed consent\n\nExclusion Criteria:\n\n* Low or intermediate complexity laparoscopic procedures (BUPA 'SIMPLE' or 'INTER')\n* Known or suspected neuromuscular disorders impairing neuromuscular function\n* Allergies to muscle relaxants, anesthetics or narcotics mentioned in paragraph 5.2\n* A (family) history of malignant hyperthermia\n* Women who are or may be pregnant or are currently breast feeding\n* Chronic use of any type of opioid or psychotropic drug\n* Use of NSAID's shorter than 5 days before surgery\n* Indication for rapid sequence induction\n* Contra-indication for sugammadex use (e.g. known sugammadex allergy or Glomerular Filtration Rate \\<30 ml/min)"}, 'identificationModule': {'nctId': 'NCT04124757', 'acronym': 'EURORELAX', 'briefTitle': 'Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'The Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety During Laparoscopic Surgery: a Multicenter Strategy Study', 'orgStudyIdInfo': {'id': 'P19.065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard neuromuscular blockade', 'description': 'Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions'}, {'type': 'EXPERIMENTAL', 'label': 'Deep neuromuscular block', 'description': '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', 'interventionNames': ['Other: Deep neuromuscular block']}], 'interventions': [{'name': 'Deep neuromuscular block', 'type': 'OTHER', 'otherNames': ['High dose rocuronium'], 'description': 'Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count', 'armGroupLabels': ['Deep neuromuscular block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Meurthe-et-Moselle', 'country': 'France', 'facility': 'Université De Lorraine', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Nazionale Dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '6525GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'RadboudUMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '2333ZA', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'LUMC', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '1815 JD', 'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Noordwest ziekenhuis groep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Netherlands Cancer institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Canisius Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari I Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Monique van Velzen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LUMC'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': 'Protocol and SAP will be published before start study. CSR will be reported after article publication in a peer reviewed journal.', 'accessCriteria': 'To be declared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Martijn Boon', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}