Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-06 @ 10:08 PM
Study NCT ID:
NCT02521259
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ladydaisy82@naver.com', 'phone': '+821086307701', 'title': 'Dr. YEA JI LEE', 'organization': 'Seoul National University Bundang Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected every 6 months.', 'description': "In this study, the concentration of inhalational agent was conventional in both group. We didn't manage the concentation intentionally to make BIS lower than 40 even in Low BIS Group. There were no adverse event and/or serious adverse event.", 'eventGroups': [{'id': 'EG000', 'title': 'Low Bispectral Index (BIS) Group', 'description': "BIS range under 40\n\nBIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.", 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal BIS Group', 'description': "BIS range from 40 to 60\n\nBIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.", 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the Pediatric Anesthesia Emergence Delirium (PAED) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Bispectral Index (BIS) Group', 'description': "BIS range under 40\n\nBIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."}, {'id': 'OG001', 'title': 'Normal BIS Group', 'description': "BIS range from 40 to 60\n\nBIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."}], 'classes': [{'title': 'T1 (on arrival PACU)', 'categories': [{'measurements': [{'value': '12.5', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'T2 (15 minutes after T1)', 'categories': [{'measurements': [{'value': '6.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'T3 (15 minutes after T2)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Bispectral Index (BIS) Group', 'description': "Bispectral index (BIS) range from 40 to 60\n\nBIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."}, {'id': 'FG001', 'title': 'Low Bispectral Index (BIS) Group', 'description': "BIS range under 40\n\nBIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Bispectral Index (BIS) Group', 'description': "BIS range under 40\n\nBIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."}, {'id': 'BG001', 'title': 'Normal BIS Group', 'description': "BIS range from 40 to 60\n\nBIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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.'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-26', 'studyFirstSubmitDate': '2015-08-10', 'resultsFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2015-08-11', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-26', 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Pediatric Anesthesia Emergence Delirium (PAED) Score', 'timeFrame': '30 minutes', 'description': 'Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anesthetic depth', 'emergence agitation'], 'conditions': ['Strabismus']}, 'descriptionModule': {'briefSummary': 'This study evaluates the association between the depth of general anesthesia and the occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery compared to the deep level of anesthetic depth.', 'detailedDescription': 'EA is characterized by dissociated state of consciousness, in which the children are inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent.\n\nSeveral predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head \\& neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.\n\nThe effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically.\n\nIn this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients, aged between 3 and 5 years, scheduled for strabismus surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 3 and 5 years\n* American Society of Anesthesiologists physical status I or II\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists physical status over III,\n* any disease that could affect mental status\n* pre-existing forehead wound'}, 'identificationModule': {'nctId': 'NCT02521259', 'briefTitle': 'Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'The Correlation Between Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery', 'orgStudyIdInfo': {'id': 'B-1503-289-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'low Bispectral index (BIS) group', 'description': 'BIS range under 40', 'interventionNames': ['Device: BIS']}, {'label': 'normal BIS group', 'description': 'BIS range from 40 to 60', 'interventionNames': ['Device: BIS']}], 'interventions': [{'name': 'BIS', 'type': 'DEVICE', 'description': "BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.", 'armGroupLabels': ['low Bispectral index (BIS) group', 'normal BIS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam', 'state': 'Gyenggo-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital, department of Anesthesia and pain', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'overallOfficials': [{'name': 'HYO SEOK NA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'LEE YEA JI', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}