Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-29 @ 5:46 PM
Study NCT ID:
NCT03170661
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2017-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'g.h.m.honing@lumc.nl', 'phone': '0715264038', 'title': 'Drs. Maarten Honing', 'organization': 'LUMC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Seven days post-procedure follow-up period', 'description': 'The definition of adverse events is comparable to the definition by this website', 'eventGroups': [{'id': 'EG000', 'title': 'Moderate NMB', 'description': 'Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 3, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Deep NMB', 'description': 'In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 2, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Postoperative CT-scan', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reflex syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'prolonged hospital stay', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hospital readmission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '2'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Leiden Surgical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Block', 'description': 'Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Block', 'description': 'Subjects will receive deep neuromuscular block, aimed at 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': '4.8', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG001'], 'statisticalMethod': 'GEEGLM', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Effects of GEEGLM covariates: surgeon, p = 0.24; surgery length, p= 0.73 and body mass index, p= 0.22).'}], 'paramType': 'MEAN', 'timeFrame': 'during surgery', 'description': 'During the on average 3 hour procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale at 15 minute intervals(1: poor ; 5: optimal) Mean and standard deviation of the average of all leiden surgical rating scale will be reported.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Measurements and Outcomes; Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Block', 'description': 'Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Block', 'description': 'In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals', 'description': 'Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period\n\n-mean pain scores (numeric rating scale; 0 no pain - 10 worst pain imaginable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraoperative Hemodynamic Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Block', 'description': 'Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Block', 'description': 'Subjects will receive deep neuromuscular block, aimed at 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': '84', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '103'}, {'value': '85', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '105'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Perioperative measurements at 15 minute interval (on average during 3 hours)', 'description': 'Perioperative average blood pressure will be reported, mean blood pressure ranging from 65 tot 110 millimeters mercury is considered normal', 'unitOfMeasure': 'millimeters mercury', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Measurements and Outcomes; Sedation Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Block', 'description': 'Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Block', 'description': 'In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals', 'description': 'Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period\n\n-ramsay sedation levels (0 = normal alertness, eyes open, responds normal to command 1 = drowsy with open eyes, closed and opened on command 2 = drowsy with closed eyes, opened in response to light auditory stimulus 3 = eyes closed, opened in response to rubbing the shoulder or a loud auditory stimulus 4 = eyes closed and opened only briefly in response to touching the subject 5 = eyes closed, unarousable by touch, aroused by painful 6 = unarousable by pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Measurements and Outcomes; Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Block', 'description': 'Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Block', 'description': 'In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'spread': '1', 'groupId': 'OG000'}, {'value': '98', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals', 'description': 'Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period\n\n-blood oxygen saturation in percent levels between 95-100 are considered normal', 'unitOfMeasure': 'percentage of blood oxygen saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraoperative Nociception Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Block', 'description': 'Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Block', 'description': 'Subjects will receive deep neuromuscular block, aimed at 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': '11', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '42'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Perioperative measurements at 15 minute interval (on average during 3 hours)', 'description': 'The median and full range of the average nociception level index will be reported.\n\nThe nociception level index consist of Ta multiparameter nonlinear combination of heart rate, heart rate variability, amplitude of the finger photoplethysmogram, skin conductance level, fluctuations in skin conductance, and their time derivatives, derived from random forest regression. Random forest is an algorithmic modeling approach that enables combining multiple parameters of different origin and discovering their complex nonlinear interactions. Normal range is between 10-20; 0 indicates no nociceptive events (in example, pain stimuli), 100 indicates severe painful stimuli.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Moderate Neuromuscular Block', 'description': 'Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four'}, {'id': 'FG001', 'title': 'Deep Neuromuscular Block', 'description': 'Subjects will receive deep neuromuscular block, aimed at 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': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Moderate Neuromuscular Block', 'description': 'Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake.'}, {'id': 'BG001', 'title': 'Deep Neuromuscular Block', 'description': 'In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '77'}, {'value': '51', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '84'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Procedure', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Laparoscopic renal surgery'}, {'title': 'Height (m)', 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '1.75', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '1.75', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '80', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '81.4', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '80.7', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'American Society of Anesthesiologists physical status classification system', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'I A normal healthy patient II A patient with mild systemic disease III A patient with severe systemic disease IV A patient with severe systemic disease that is a constant threat to life V A moribund patient who is not expected to survive without the operation VI A declared brain-dead patient whose organs are being removed for donor purposes', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-01', 'size': 462681, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-16T09:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-21', 'studyFirstSubmitDate': '2017-04-25', 'resultsFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2017-05-26', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-02', 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leiden Surgical Rating Scale', 'timeFrame': 'during surgery', 'description': 'During the on average 3 hour procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale at 15 minute intervals(1: poor ; 5: optimal) Mean and standard deviation of the average of all leiden surgical rating scale will be reported.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Measurements and Outcomes; Pain Scores', 'timeFrame': 'During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals', 'description': 'Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period\n\n-mean pain scores (numeric rating scale; 0 no pain - 10 worst pain imaginable)'}, {'measure': 'Intraoperative Hemodynamic Conditions', 'timeFrame': 'Perioperative measurements at 15 minute interval (on average during 3 hours)', 'description': 'Perioperative average blood pressure will be reported, mean blood pressure ranging from 65 tot 110 millimeters mercury is considered normal'}, {'measure': 'Postoperative Measurements and Outcomes; Sedation Levels', 'timeFrame': 'During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals', 'description': 'Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period\n\n-ramsay sedation levels (0 = normal alertness, eyes open, responds normal to command 1 = drowsy with open eyes, closed and opened on command 2 = drowsy with closed eyes, opened in response to light auditory stimulus 3 = eyes closed, opened in response to rubbing the shoulder or a loud auditory stimulus 4 = eyes closed and opened only briefly in response to touching the subject 5 = eyes closed, unarousable by touch, aroused by painful 6 = unarousable by pain)'}, {'measure': 'Postoperative Measurements and Outcomes; Saturation', 'timeFrame': 'During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals', 'description': 'Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period\n\n-blood oxygen saturation in percent levels between 95-100 are considered normal'}, {'measure': 'Intraoperative Nociception Level', 'timeFrame': 'Perioperative measurements at 15 minute interval (on average during 3 hours)', 'description': 'The median and full range of the average nociception level index will be reported.\n\nThe nociception level index consist of Ta multiparameter nonlinear combination of heart rate, heart rate variability, amplitude of the finger photoplethysmogram, skin conductance level, fluctuations in skin conductance, and their time derivatives, derived from random forest regression. Random forest is an algorithmic modeling approach that enables combining multiple parameters of different origin and discovering their complex nonlinear interactions. Normal range is between 10-20; 0 indicates no nociceptive events (in example, pain stimuli), 100 indicates severe painful stimuli.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Conditions']}, 'descriptionModule': {'briefSummary': 'A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.', 'detailedDescription': 'Neuromuscular blocking agents (NMBAs) are routinely administered during general anaesthesia to facilitate endotracheal intubation and to optimize surgical conditions. Increasing data suggest superiority of a deep neuromuscular block (defined by a post-tetanic count of 1-2 twitches) in creating optimal working conditions for the surgical team. However, it is unknown whether other aspects of the anaesthetic technique, most notably the choice of anaesthetic (for example, total intravenous versus inhalational anaesthesia), influence the relationship between the depth of the neuromuscular block and surgical conditions, particularly in laparoscopic surgery. Volatile anaesthetics are known for their ability to potentiate neuromuscular blocking agents an effect that is less existent with propofol. We previously showed that surgical working conditions in laparoscopic surgery during propofol anaesthesia are highly reliant on the depth of the neuromuscular block. Whether such a relationship also exists for inhalational anaesthetics, is unknown. To investigate this, we conducted a prospective, randomized, double blind study in which patients scheduled for laparoscopic renal surgery were randomized to receive either a moderate or a deep neuromuscular block during sevoflurane anaesthesia. The primary outcome was the intraoperative surgical condition assessed by a surgeon using the validated Leiden-Surgical Rating Scale. We hypothesized that the use of an inhalational anaesthetic would obviate the need for a deep NMB due to its intrinsic muscle relaxant potentiating properties to produce optimal working conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;\n* American Society of Anesthesiologists (ASA) class I-III\n* \\> 18 years of age;\n* Ability to give oral and written informed consent.\n\nExclusion Criteria:\n\n* Known or suspected neuromuscular disorders impairing neuromuscular function;\n* Allergies to muscle relaxants, anesthetics or narcotics;\n* A (family) history of malignant hyperthermia;\n* Women who are or may be pregnant or are currently breast feeding;\n* Renal insufficiency, as defined by glomerular filtration rate \\< 30 ml/h creatinine.\n* Previous retroperitoneal surgery at the site of the current surgery.\n* Body mass index \\> 35 kg/m2'}, 'identificationModule': {'nctId': 'NCT03170661', 'acronym': 'BLISS4', 'briefTitle': 'Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions in Patients Undergoing Laparoscopic Renal Surgery', 'orgStudyIdInfo': {'id': 'p17.049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Moderate neuromuscular block', 'description': 'Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four'}, {'type': 'EXPERIMENTAL', 'label': 'Deep neuromuscular block', 'description': 'Subjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count', 'interventionNames': ['Drug: Deep neuromuscular block']}], 'interventions': [{'name': 'Deep neuromuscular block', 'type': 'DRUG', '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': [{'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Albert Dahan, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Albert Dahan', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}