Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT02320734
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2014-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-09-13', 'releaseDate': '2021-08-17'}, {'resetDate': '2023-09-14', 'releaseDate': '2022-11-11'}], 'estimatedResultsFirstSubmitDate': '2021-08-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2014-12-12', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'length of stay ICU/PACU', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'need for re-intubation', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'post-operative surgical complications', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}, {'measure': 'VAS-scores', 'timeFrame': '24-hours post operation'}, {'measure': 'Abdominal and thoracic insufflation pressures', 'timeFrame': 'During operation'}], 'primaryOutcomes': [{'measure': 'Rating of surgical conditions (SRS) during the abdominal phase of the operation.', 'timeFrame': 'during operation'}], 'secondaryOutcomes': [{'measure': 'Rating of SRS during thoracic phase of the operation.', 'timeFrame': 'during operation'}, {'measure': 'Number of on demand boluses infused, indication of on demand bolus administration', 'timeFrame': 'during operation'}, {'measure': 'Rating of anesthesia conditions', 'timeFrame': 'during operation', 'description': 'peak and mean respiratory pressure, incidence peak insufflation pressure \\>35 mmHg. Depth of NBM at the end of surgery. Time until spontaneous breathing, time until extubation. Peroperative cardiac and respiratory incidents, peroperative surgical complications.Tiem to reversal of NMB, % of recurarisation'}, {'measure': "Costs (euro's) associated with use of Rocuronium, Sugammadex, operation time and length of stay ICU.", 'timeFrame': 'during operation and an average of 4 weeks thereafter', 'description': 'amount of rocuronium used (mg); Dose of sugammadex needed (mg), duration of surgery, hypothetical need for post-operative ventilation if sugammadex would not be available(%).'}, {'measure': 'Number of correct estimates of group randomization by surgeons', 'timeFrame': 'directly after operation', 'description': 'Surgeons will guess in which group the patient was randomized (%) and the reason for this choice will be registrated. Accordingly we can estimate whether the surgeons complaints of inadequate NMB are justified and additionally, the chance of bias affecting main outcome parameter.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['surgical rating scale', 'neuromuscular relaxation', 'Anaesthesia', 'minimally invasive esophagectomy'], 'conditions': ['Neuromuscular Block', 'Esophageal Cancer', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '31025258', 'type': 'DERIVED', 'citation': 'Veelo DP, Gisbertz SS, Binnekade JM, Hannivoort RA, Bosman JA, Geerts BF, Blobner M, van Berge Henegouwen MI, Hollmann MW. On-demand versus continuous rocuronium infusion for deep neuromuscular relaxation in patients undergoing thoraco-laparoscopic esophagectomy: a randomized-controlled clinical trial (DEPTH). Can J Anaesth. 2019 Sep;66(9):1062-1074. doi: 10.1007/s12630-019-01373-0. Epub 2019 Apr 25.'}, {'pmid': '26242177', 'type': 'DERIVED', 'citation': 'Veelo DP, Gisbertz SS, Hannivoort RA, van Dieren S, Geerts BF, van Berge Henegouwen MI, Hollmann MW. The effect of on-demand vs deep neuromuscular relaxation on rating of surgical and anaesthesiologic conditions in patients undergoing thoracolaparoscopic esophagectomy (DEPTH trial): study protocol for a randomized controlled trial. Trials. 2015 Aug 5;16:331. doi: 10.1186/s13063-015-0849-0.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia conditions. Under these conditions, boluses of muscle relaxants can be given on indication only OR by continuous infusion. We hypothesize that deep NMB by continuous infusion of rocuronium as compared to on demand bolus administration facilitates surgical and anesthesia conditions during thoraco-laparoscopic esophageal resection but higher doses of sugammadex are needed to reverse NMB at the end of surgery.\n\nObjective: Primary objective is to evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed in both groups in an economical perspective and to compare the intra-operative cardiac and respiratory incidents and post-operative complication rate of both groups.\n\nStudy design: a single-center randomized controlled double-blinded intervention study.\n\nStudy population: All patients \\> 18 years to undergo a thoracolaparoscopic esophageal resection.I Intervention: Patients are randomized to receive either continuous infusion of rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.\n\nMain study parameters/endpoints: The primary outcome parameter of this study is the SRS during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes measured are SRS during the thoracic phase, the number of on demand boluses infused, the dose of Sugammadex needed in both groups to reach a TOF of \\> 90%, duration of surgery, a cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the ability of surgeons to estimate which neuromuscular blocking regime was given to the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, undergoing elective thoraco-laparoscopic esophageal resection (either Ivor Lewis or McKeown variant)\n* Written informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* Known allergies for aminosteroid-type muscle relaxants or sugammadex.\n* Severe kidney dysfunction (GFR \\< 30), patients on dialysis\n* Liver function disorders\n* Myasthenia Gravis or other (neuro)muscular diseases\n* Patients with carcinomatosis\n* Use of anti-epileptics and lithium or drugs containing Kinin'}, 'identificationModule': {'nctId': 'NCT02320734', 'acronym': 'DEPTH', 'briefTitle': 'Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'A Randomized Controlled Double-blinded Trial Comparing the Effect of on Demand vs Deep Neuromuscular Relaxation on Rating of Surgical and Anesthesia Conditions in Patients Undergoing Thoraco-laparoscopic Esophagectomy', 'orgStudyIdInfo': {'id': '2014-211'}, 'secondaryIdInfos': [{'id': '2014-002147-18', 'type': 'EUDRACT_NUMBER'}, {'id': 'MISP51412', 'type': 'OTHER_GRANT', 'domain': 'Merck Sharp & Dohme BV'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'deep neuromuscular relaxation', 'description': 'continuous infusion of rocuronium 0.6 mg/kg/hr (group 1). On demand bolus rocuronium can be given if demanded by anesthesiologist or surgeon', 'interventionNames': ['Drug: Rocuronium']}, {'type': 'NO_INTERVENTION', 'label': 'on demand neuromuscular relaxation', 'description': 'continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2) On demand bolus of Rocuronium will be given when demanded by anesthesiologist or surgeon.'}], 'interventions': [{'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['Esmeron'], 'description': 'Rocuronium given continuously to reach deep neuromuscular block', 'armGroupLabels': ['deep neuromuscular relaxation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Markus W Hollmann, prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'Denise P Veelo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'D.P.Veelo', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-08-17', 'type': 'RELEASE'}, {'date': '2021-09-13', 'type': 'RESET'}, {'date': '2022-11-11', 'type': 'RELEASE'}, {'date': '2023-09-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Denise P. Veelo, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}