Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-07 @ 10:01 AM
Study NCT ID:
NCT01545193
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2012-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000375', 'term': 'Aging'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dgmurphy2@yahoo.com', 'phone': '847-570-2760', 'title': 'Glenn S. Murphy,MD', 'organization': 'NorthShore University HealthSystem'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of hospitalization, which ranged from 1 to 10 days', 'eventGroups': [{'id': 'EG000', 'title': 'Age 18-50', 'description': 'This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade', 'otherNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Age 70-90', 'description': 'This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade', 'otherNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Residual Neuromuscular Blockade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 18-50', 'description': 'This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}, {'id': 'OG001', 'title': 'Age 70-90', 'description': 'This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Early postoperative period, up to 24 hours', 'description': 'The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios \\< 0.9 in each group will be compared.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Signs and Symptoms of Residual Neuromuscular Blockade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 18-50', 'description': 'This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}, {'id': 'OG001', 'title': 'Age 70-90', 'description': 'This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Early postoperative period, up to 24 hours', 'description': 'A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission. Reported data is the total number of symptoms (0-16) at PACU admission', 'unitOfMeasure': 'symptoms', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Respiratory Events Potentially Related to Residual Neuromuscular Blockade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 18-50', 'description': 'This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}, {'id': 'OG001', 'title': 'Age 70-90', 'description': 'This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Early postoperative period, up to 24 hours', 'description': 'Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Data reported are the number of patients developing hypoxemia (oxygen saturation \\< 94% on pulse oximetry) in the PACU', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PACU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age 18-50', 'description': 'This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}, {'id': 'OG001', 'title': 'Age 70-90', 'description': 'This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '102'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '125'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Early postoperative period, up to 24 hours', 'description': 'The time required to meet discharge criteria and achieve actual discharge will be noted.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Age 18-50', 'description': 'This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}, {'id': 'FG001', 'title': 'Age 70-90', 'description': 'This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Age 18-50', 'description': 'This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}, {'id': 'BG001', 'title': 'Age 70-90', 'description': 'This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade\n\nAge and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade'}, {'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': '150', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '46'}, {'value': '75', 'groupId': 'BG001', 'lowerLimit': '72', 'upperLimit': '80'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-12', 'studyFirstSubmitDate': '2012-03-01', 'resultsFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-03', 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Residual Neuromuscular Blockade', 'timeFrame': 'Early postoperative period, up to 24 hours', 'description': 'The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios \\< 0.9 in each group will be compared.'}], 'secondaryOutcomes': [{'measure': 'Signs and Symptoms of Residual Neuromuscular Blockade', 'timeFrame': 'Early postoperative period, up to 24 hours', 'description': 'A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission. Reported data is the total number of symptoms (0-16) at PACU admission'}, {'measure': 'Respiratory Events Potentially Related to Residual Neuromuscular Blockade', 'timeFrame': 'Early postoperative period, up to 24 hours', 'description': 'Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Data reported are the number of patients developing hypoxemia (oxygen saturation \\< 94% on pulse oximetry) in the PACU'}, {'measure': 'PACU Length of Stay', 'timeFrame': 'Early postoperative period, up to 24 hours', 'description': 'The time required to meet discharge criteria and achieve actual discharge will be noted.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Elderly', 'Residual neuromuscular blockade'], 'conditions': ['Residual Neuromuscular Blockade in Elderly Patients']}, 'descriptionModule': {'briefSummary': 'Residual neuromuscular blockade is frequently observed in the early postoperative period when patients have received a general anesthetic with muscle relaxants. At the present time it is uncertain whether certain patient populations are at greater risk for this common anesthetic complication. However, it is possible that elderly surgical patients may exhibit a higher incidence of residual neuromuscular blockade. The aim of this clinical trial is to determine the incidence of residual neuromuscular blockade in a cohort of younger (ages 18-50) and older (ages 70-90) patients undergoing surgery and general anesthesia.', 'detailedDescription': '300 patients will be enrolled in this study. Patients will be selected for enrollment by reviewing the operating room schedule on the day prior to the procedure. Two groups of patients will be examined; group 1 will consist of patients ages 18-50 (n=150) and group 2 will consist of patients age 70-90 (n=150). Patients will be enrolled in blocks of 20 to ensure an equal distribution of subjects in each age group over time.\n\nAnesthetic and neuromuscular management will be standardized in both study cohorts\n\nNeuromuscular Monitoring:\n\nOn arrival to the PACU, a blinded research assistant will obtain a quantitative TOF measurement in all subjects. The TOF-Watch SX will be used to obtain these measurements. Two consecutive responses to TOF stimulation (separated by \\> 15 seconds) will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios \\< 0.7, 0.8, and 0.9 (which are levels of residual neuromuscular block associated with various adverse clinical outcomes) in each group will be compared.\n\nSigns and Symptoms of Residual Neuromuscular Blockade After TOF data is collected on arrival to the PACU, the patients will be carefully examined for signs and symptoms of muscle weakness by a blinded research assistant. A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission.\n\nRespiratory Events Potentially Related to Residual Neuromuscular Blockade\n\nPulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Patients will be transported to the PACU without supplemental oxygen (unless the anesthesia care provider determines that oxygen therapy is required for patient safety-per standard practice). All patients will be placed on 2 liters nasal cannula oxygen in the PACU. In the PACU, pulse oximetry will be used to continuously measure Sp02. Oxygenation data will be stored and recorded every minute for the first 30 minutes of the PACU admission. In addition to oxygenation data, patients will be assessed during transportation to the PACU and during the first 30 minutes of the PACU admission for evidence of airway obstruction.\n\nPACU Length of Stay The impact of age and residual blockade on length of PACU stay will be determined. The time required to meet discharge criteria and achieve actual discharge will be noted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing general anesthesia and surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting for elective surgical procedures with an expected duration greater than 45 minutes.\n* ASA I to III patients ≥ 18 years of age, presenting for surgery requiring maintenance of neuromuscular blockade in the operating room, will be eligible for enrollment.\n\nExclusion Criteria:\n\n1. presence of an underlying neuromuscular disease\n2. use of drugs known to interfere with neuromuscular transmission (antiseizure medications, anticholinesterases, magnesium sulfate)\n3. renal insufficiency (serum creatinine \\> 1.8 mg/dL) or renal failure.'}, 'identificationModule': {'nctId': 'NCT01545193', 'briefTitle': 'The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade', 'organization': {'class': 'OTHER', 'fullName': 'Endeavor Health'}, 'officialTitle': 'The Effect of Age on the Incidence of Postoperative Residual Neuromuscular Blockade', 'orgStudyIdInfo': {'id': 'EH11-045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Age 18-50', 'description': 'This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade', 'interventionNames': ['Other: Age and incidence of residual neuromuscular blockade']}, {'label': 'Age 70-90', 'description': 'This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade', 'interventionNames': ['Other: Age and incidence of residual neuromuscular blockade']}], 'interventions': [{'name': 'Age and incidence of residual neuromuscular blockade', 'type': 'OTHER', 'description': 'An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade', 'armGroupLabels': ['Age 18-50', 'Age 70-90']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'overallOfficials': [{'name': 'Glenn S. Murphy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endeavor Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endeavor Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Cardiac Anesthesia and Clinical Research', 'investigatorFullName': 'Glenn Murphy', 'investigatorAffiliation': 'Endeavor Health'}}}}