Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:10 AM
Study NCT ID:
NCT02838134
Status:
COMPLETED
Last Update Posted:
2019-09-19
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
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': 'Michiel.Warlé@radboudumc.nl', 'phone': '+31-24362415333', 'title': 'Dr M.C. Warlé', 'organization': 'Radboud University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It appeared to be difficult to achieve and maintain the intended depth of neuromuscular blockade. Despite high dosages of rocuronium with continuous infusion, the intended deep NMB was not achieved in all patients within the deep NMB group.'}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 9, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 5, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '169.3', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '169.5', 'spread': '15.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1: 24 hours after detubation', 'description': "The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Explanation of missing data:\n\nOne patient from group A missed one page of the QOR-40 questionnaire on postoperative day 1.\n\nOne patient from group B did not complete the questionnaires on postoperative days 1 and 2 because of personal circumstances'}, {'type': 'SECONDARY', 'title': 'Surgical Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)', 'description': 'Surgical rating score, concerning the quality of the surgical field, scored with the surgical rating scale (SRS) A likert scale from 1 to 5. Higher scores represent better outcomes.\n\n1. = extremely poor conditions\n2. = poor conditions\n3. = acceptable conditions\n4. =good conditions\n5. = optimal conditions', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Pneumoperitoneum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '122.8', 'spread': '44.5', 'groupId': 'OG000'}, {'value': '113.8', 'spread': '39.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Intraoperative parameter of duration of pneumoperitoneum', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Warm Ischemia Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Intraoperative parameter measuring the time (in minutes) between dissection of the renal artery and flushing of the kidney after retrieval', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'spread': '68.5', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '72.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Intraoperative parameter', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Number of Participants with conversion to open or hand-assisted donor nephrectomy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intra-operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Number of Participants with Complications which occurred during surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Use of Rocuronium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '184.6', 'spread': '83.1', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '41.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Total amount of rocuronium administered during surgery', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Score of the Quality of Recovery-40 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '175.6', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '175.3', 'spread': '16.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2: 48 hours after detubation', 'description': "The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'title': 'Overall_1h (PACU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Referred pain_1h (PACU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'overall_6h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Referred pain_6h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Overall_POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Referred pain+POD1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Overall_POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Referred pain_POD2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation', 'description': 'components of pain scores after 1 hour, 6 hours, on postoperative day 1 (POD1) and postoperative day 2 (POD2).\n\nLikert scale from 0 to 10. Higher scores represent more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient from the moderate NMB group was not able to complete the questionnaires on day 1 and day 2 because of personal circumstances.'}, {'type': 'SECONDARY', 'title': 'Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'title': 'during hospital stay', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '30 days after surgery', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '60 days after surgery', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery', 'description': 'Number of participants with postoperative complications that occurred up to 8 weeks after surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Discharge Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'title': 'reached all criteria after 24hours', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'reached all criteria after 48 hours', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 and 48 hours after detubation', 'description': 'Scoring the following criteria: adequate pain control with oral medication, passage of flatus or defecation, intake of solid food tolerated, patient is mobilized and independent and patient accepts discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'OG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.88', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '1.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'once, 4 weeks after surgery', 'description': 'Total amount of pain 4 weeks after surgery Likert scale from 0 to 10. Higher scores represent more pain (worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.'}, {'id': 'FG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'logistic problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '26 patients were assessed for eligibility but excluded, 8 patients did not meet the inclusion criteria 18 patients declined to participate'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A: Deep Neuromuscular Blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion\n\nRocuronium: A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when PTC is more than 0 and titrated towards PTC 1-2.'}, {'id': 'BG001', 'title': 'Group B: Moderate Neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.\n\nNo additional Rocuronium: No additional rocuronium is administered after tracheal intubation.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.7', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '56.6', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Distribution of participants per sex', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.7', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '26.5', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '26.6', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Centre', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Radboud', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'LUMC', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Distribution of participants per centre', 'unitOfMeasure': 'Participants'}, {'title': 'Previous abdominal surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with previous abdominal surgery', 'unitOfMeasure': 'Participants'}, {'title': 'Previous pregnancies', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with previous pregnancies', 'unitOfMeasure': 'Participants'}, {'title': 'Side of nephrectomy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Left', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Right', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Distribution of participants per side of nephrectomy', 'unitOfMeasure': 'Participants'}, {'title': 'Vascular anatomy (more than one renel artery or renal vein)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with more than one renal artery or renal vein', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-23', 'size': 828181, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-15T15:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-16', 'studyFirstSubmitDate': '2016-06-29', 'resultsFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2016-07-15', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-16', 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)', 'timeFrame': 'Day 1: 24 hours after detubation', 'description': "The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome"}], 'secondaryOutcomes': [{'measure': 'Surgical Conditions', 'timeFrame': 'Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)', 'description': 'Surgical rating score, concerning the quality of the surgical field, scored with the surgical rating scale (SRS) A likert scale from 1 to 5. Higher scores represent better outcomes.\n\n1. = extremely poor conditions\n2. = poor conditions\n3. = acceptable conditions\n4. =good conditions\n5. = optimal conditions'}, {'measure': 'Length of Pneumoperitoneum', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Intraoperative parameter of duration of pneumoperitoneum'}, {'measure': 'Warm Ischemia Time', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Intraoperative parameter measuring the time (in minutes) between dissection of the renal artery and flushing of the kidney after retrieval'}, {'measure': 'Estimated Blood Loss', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Intraoperative parameter'}, {'measure': 'Conversion', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Number of Participants with conversion to open or hand-assisted donor nephrectomy'}, {'measure': 'Intra-operative Complications', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Number of Participants with Complications which occurred during surgery'}, {'measure': 'Cumulative Use of Rocuronium', 'timeFrame': 'Day 0: once, up to 240 minutes', 'description': 'Total amount of rocuronium administered during surgery'}, {'measure': 'Total Score of the Quality of Recovery-40 Questionnaire', 'timeFrame': 'Day 2: 48 hours after detubation', 'description': "The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome."}, {'measure': 'Postoperative Pain', 'timeFrame': 'Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation', 'description': 'components of pain scores after 1 hour, 6 hours, on postoperative day 1 (POD1) and postoperative day 2 (POD2).\n\nLikert scale from 0 to 10. Higher scores represent more pain.'}, {'measure': 'Postoperative Complications', 'timeFrame': '24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery', 'description': 'Number of participants with postoperative complications that occurred up to 8 weeks after surgery'}, {'measure': 'Discharge Criteria', 'timeFrame': '24 and 48 hours after detubation', 'description': 'Scoring the following criteria: adequate pain control with oral medication, passage of flatus or defecation, intake of solid food tolerated, patient is mobilized and independent and patient accepts discharge.'}, {'measure': 'Pain Scores', 'timeFrame': 'once, 4 weeks after surgery', 'description': 'Total amount of pain 4 weeks after surgery Likert scale from 0 to 10. Higher scores represent more pain (worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laparoscopic donor nephrectomy', 'Early quality of recovery'], 'conditions': ['Neuromuscular Block', 'Renal Transplant Donor of Left Kidney', 'Renal Transplant Donor of Right Kidney', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '34879862', 'type': 'DERIVED', 'citation': "Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1."}, {'pmid': '32107359', 'type': 'DERIVED', 'citation': 'Albers KI, van Helden EV, Dahan A, Martini CH, Bruintjes MHD, Scheffer GJ, Steegers MAH, Keijzer C, Warle MC. Early postoperative pain after laparoscopic donor nephrectomy predicts 30-day postoperative infectious complications: a pooled analysis of randomized controlled trials. Pain. 2020 Jul;161(7):1565-1570. doi: 10.1097/j.pain.0000000000001842.'}, {'pmid': '30920983', 'type': 'DERIVED', 'citation': "Bruintjes MHD, Krijtenburg P, Martini CH, Poyck PP, d'Ancona FCH, Huurman VAL, van der Jagt M, Langenhuijsen JF, Nijboer WN, van Laarhoven CJHM, Dahan A, Warle MC; RELAX collaborator group. Efficacy of profound versus moderate neuromuscular blockade in enhancing postoperative recovery after laparoscopic donor nephrectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):494-501. doi: 10.1097/EJA.0000000000000992."}, {'pmid': '28259181', 'type': 'DERIVED', 'citation': "Bruintjes MH, Braat AE, Dahan A, Scheffer GJ, Hilbrands LB, d'Ancona FC, Donders RA, van Laarhoven CJ, Warle MC. Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study. Trials. 2017 Mar 4;18(1):99. doi: 10.1186/s13063-017-1785-y."}]}, 'descriptionModule': {'briefSummary': "Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions. The investigators' goal is to establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the investigators designed a trial in which patients scheduled for living donor nephrectomy are randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.", 'detailedDescription': 'Rationale: Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade (NMB) has shown to reduce postoperative pain scores after laparoscopic surgery. With this study the investigators will investigate if deep NMB also improves the early quality of recovery after LDN.\n\nObjective: To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) - with standard pressure pneumoperitoneum - and the early quality of recovery.\n\nStudy design: A multicenter, blinded, randomized controlled trial\n\nStudy population: 96 adult patients (18 years or older), scheduled for living donor nephrectomy, will be randomized into a group with deep or moderate neuromuscular blockade. Deep neuromuscular blockade is defined as post tetanic count 1-2.\n\nMain study parameters/endpoints: The primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.\n\nSecondary outcomes measured are: intra-operative parameters (e.g. surgical conditions, operation time, length of pneumoperitoneum, first warm ischemia time, estimated blood loss, conversion to open or hand-assisted donor nephrectomy, intra-operative complications, cumulative use of rocuronium and sugammadex), the total score of the quality of Recovery-40 questionnaire at 48 hours after extubation, post-operative pain (components of pain scores); postoperative nausea and vomiting (NRS), the cumulative use of analgesics and anti-emetics, time to reach discharge criteria and postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'All adult individuals, who are scheduled for living kidney donation.\n\nInclusion Criteria:\n\n* obtained informed consent\n* age over 18 years\n\nExclusion Criteria:\n\n* insufficient control of the Dutch language to read the patient information and to fill out the questionnaires\n* chronic use of analgesics or psychotropic drugs\n* use of NSAIDs shorter than 5 days before surgery\n* known or suspect allergy to rocuronium of sugammadex\n* neuromuscular disease\n* indication for rapid sequence induction\n* deficiency of vitamin K-dependent clotting factors, coagulopathy or active use of coumarin derivates.\n* Peri-operative use of fusidic acid or flucloxacillin\n* Severe renal impairment (creatinine clearance \\<30ml/min)\n* Morbid obesity (BMI\\>35 kg/m2)'}, 'identificationModule': {'nctId': 'NCT02838134', 'acronym': 'RELAX', 'briefTitle': 'Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'The Effectiveness of Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery', 'orgStudyIdInfo': {'id': 'NL58160.091.16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Deep Neuromuscular blockade', 'description': 'An extra bolus of rocuronium after intubation followed by infusion', 'interventionNames': ['Other: Rocuronium']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group B: Moderate neuromuscular Blockade', 'description': 'Moderate neuromuscular Blockade No additional rocuronium after intubation.', 'interventionNames': ['Other: No additional Rocuronium']}], 'interventions': [{'name': 'Rocuronium', 'type': 'OTHER', 'description': 'A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.', 'armGroupLabels': ['Group A: Deep Neuromuscular blockade']}, {'name': 'No additional Rocuronium', 'type': 'OTHER', 'description': 'No additional rocuronium is administered after tracheal intubation.', 'armGroupLabels': ['Group B: Moderate neuromuscular Blockade']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'country': 'Netherlands', 'facility': 'LUMC', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Moira Bruintjes, Msc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'Michiel Warlé, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'Andries E Braat, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LUMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}