Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-20 @ 9:11 AM
Study NCT ID:
NCT00990769
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'heather.frederick@duke.edu', 'phone': '919-812-6204', 'title': 'Dr. Heather Frederick', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 55-60', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 40-45', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 55-60'}, {'id': 'OG001', 'title': 'Low-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 40-45'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'groupDescription': 'Sample size calculation concluded that 20 patients in each group would have 80% power to detect a mean difference of 4 ± 4 with alpha equal to 0.05, as would be determined by a two-sample T test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes of arrival in recovery room', 'description': 'The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in each group were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Emergence From Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 55-60'}, {'id': 'OG001', 'title': 'Low-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 40-45'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '5', 'groupId': 'OG000'}, {'value': '12', 'spread': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After the completion of surgery', 'description': 'The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients were analyzed'}, {'type': 'SECONDARY', 'title': 'Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 55-60'}, {'id': 'OG001', 'title': 'Low-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 40-45'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes of arrival in recovery room', 'description': 'Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 55-60'}, {'id': 'FG001', 'title': 'Low-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 40-45'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Signed consent and assigned to High-normal BIS', 'groupId': 'FG000', 'numSubjects': '22'}, {'comment': 'Signed consent and assigned to Low-normal BIS', 'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Parents or guardians of children undergoing ophthalmologic surgery were approached, when possible, at their pre-anesthesia evaluation visit. All eligible patients were notified about the study through fliers at their pre-operative visit, and eligible patients who were missed pre-operatively were approached for consent on the day of surgery.', 'preAssignmentDetails': 'Fifty-seven patients were approached for participation; of these, fourteen declined and three were unable to participate due to surgery cancellation or rescheduling.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 55-60'}, {'id': 'BG001', 'title': 'Low-normal BIS', 'description': 'Depth of anesthesia is titrated to a BIS level of 40-45'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', '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': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2009-10-05', 'resultsFirstSubmitDate': '2013-04-10', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-30', 'studyFirstPostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)', 'timeFrame': 'Within 30 minutes of arrival in recovery room', 'description': 'The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.'}], 'secondaryOutcomes': [{'measure': 'Time to Emergence From Anesthesia', 'timeFrame': 'After the completion of surgery', 'description': 'The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.'}, {'measure': 'Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)', 'timeFrame': 'Within 30 minutes of arrival in recovery room', 'description': 'Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emergence delirium', 'Bispectral Index', 'Depth of anesthesia'], 'conditions': ['Emergence Agitation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery\n* American Society of Anesthesiology (ASA) physical status 1 or 2\n\nExclusion Criteria:\n\n* Surgery precluding placement of BIS monitor\n* Non-English speaking, until additional language consent forms are approved\n* Previous history of severe emergence agitation'}, 'identificationModule': {'nctId': 'NCT00990769', 'briefTitle': 'The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children', 'orgStudyIdInfo': {'id': 'Pro00015531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-normal BIS ("Lighter" anesthesia)', 'description': 'Depth of anesthesia is titrated to a BIS of 55-60', 'interventionNames': ['Other: Depth of anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Low-normal BIS ("Deeper" anesthesia)', 'description': 'Depth of anesthesia is maintained at a BIS level of 40-45', 'interventionNames': ['Other: Depth of anesthesia']}], 'interventions': [{'name': 'Depth of anesthesia', 'type': 'OTHER', 'description': 'The intervention in this study is the titration of the depth of anesthesia according to the BIS monitor, as maintained by a combination of routine anesthetic agents (nitrous oxide, sevoflurane, and fentanyl).', 'armGroupLabels': ['High-normal BIS ("Lighter" anesthesia)', 'Low-normal BIS ("Deeper" anesthesia)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center - Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Heather J Frederick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Heather Frederick', 'investigatorFullName': 'Heather Frederick', 'investigatorAffiliation': 'Duke University'}}}}