Viewing Study NCT02109133


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Study NCT ID: NCT02109133
Status: COMPLETED
Last Update Posted: 2015-06-24
First Post: 2014-03-30
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Sponsor:
Organization:

Raw JSON

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Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Blockade (Deep NMB Group)', 'description': 'Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position', 'description': 'maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Surgical Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Blockade', 'description': 'moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine\n\nAtracurium\n\nNeostigmine'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Blockade', 'description': 'deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex\n\nRocuronium\n\nSugammadex'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At the end of the Steep trendelenburg position, an average of 1 hour', 'description': 'overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Post-operative Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Blockade (Moderate NMB Group)', 'description': 'Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Blockade (Deep NMB Group)', 'description': 'Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 24hours after operation', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Incidence of Residual Neuromuscular Blockade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate Neuromuscular Blockade (Moderate NMB Group)', 'description': 'Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.'}, {'id': 'OG001', 'title': 'Deep Neuromuscular Blockade (Deep NMB Group)', 'description': 'Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 24hours after operation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Moderate Neuromuscular Blockade (Moderate NMB Group)', 'description': 'Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.'}, {'id': 'FG001', 'title': 'Deep Neuromuscular Blockade (Deep NMB Group)', 'description': 'Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were screened and enrolled at 1 site in the Korea', 'preAssignmentDetails': 'No test entered'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Moderate Neuromuscular Blockade', 'description': 'moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine\n\nAtracurium\n\nNeostigmine'}, {'id': 'BG001', 'title': 'Deep Neuromuscular Blockade', 'description': 'deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex\n\nRocuronium\n\nSugammadex'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', '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': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-21', 'studyFirstSubmitDate': '2014-03-30', 'resultsFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-21', 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Post-operative Nausea', 'timeFrame': 'During 24hours after operation'}, {'measure': 'Incidence of Residual Neuromuscular Blockade', 'timeFrame': 'During 24hours after operation'}], 'primaryOutcomes': [{'measure': 'Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade', 'timeFrame': 'Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position', 'description': 'maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade'}], 'secondaryOutcomes': [{'measure': 'Overall Surgical Condition', 'timeFrame': 'At the end of the Steep trendelenburg position, an average of 1 hour', 'description': 'overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['deep neuromuscular blockade', 'intraocular pressure'], 'conditions': ['Robot-Assisted Laparoscopic Radical Prostatectomy']}, 'referencesModule': {'references': [{'pmid': '26317357', 'type': 'DERIVED', 'citation': 'Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. ASA class I-II\n2. obtaining written informed consent from the parents\n3. aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy\n\nExclusion Criteria:\n\n1. eye surgery previously\n2. unstable angina or congestive heart failure\n3. concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)\n4. high intraocular pressure over 30mmHg after screening test.\n5. uncontrolled hypertension (diastolic bp\\>110mmHg)\n6. coagulopathy\n7. asthma\n8. hepatic failure\n9. renal failure(creatinine clearance \\< 30 ml/min)\n10. drug hyperactivity\n11. neurological or psychiatric illnesses\n12. mental retardation\n13. patients who can't read the consent form due to illiterate or foreigner\n14. previous malignant hyperthermia Hx\n15. drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc)\n16. BMI \\> 30kg/m2"}, 'identificationModule': {'nctId': 'NCT02109133', 'briefTitle': 'The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep neuromuscular blockade', 'description': 'Deep neuromuscular blockade', 'interventionNames': ['Procedure: deep neuromuscular blockade', 'Drug: Rocuronium', 'Drug: Sugammadex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'moderate neuromuscular blockade', 'description': 'moderate neuromuscular blockade', 'interventionNames': ['Procedure: moderate neuromuscular blockade', 'Drug: Atracurium', 'Drug: Neostigmine']}], 'interventions': [{'name': 'deep neuromuscular blockade', 'type': 'PROCEDURE', 'description': 'deep neuromuscular blockade using rocuronium and reverse with sugammadex', 'armGroupLabels': ['Deep neuromuscular blockade']}, {'name': 'moderate neuromuscular blockade', 'type': 'PROCEDURE', 'description': 'moderate neuromuscular blockade using atracurium and reverse with neostigmine', 'armGroupLabels': ['moderate neuromuscular blockade']}, {'name': 'Rocuronium', 'type': 'DRUG', 'armGroupLabels': ['Deep neuromuscular blockade']}, {'name': 'Sugammadex', 'type': 'DRUG', 'armGroupLabels': ['Deep neuromuscular blockade']}, {'name': 'Atracurium', 'type': 'DRUG', 'armGroupLabels': ['moderate neuromuscular blockade']}, {'name': 'Neostigmine', 'type': 'DRUG', 'armGroupLabels': ['moderate neuromuscular blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}