Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-27 @ 5:20 PM
Study NCT ID:
NCT02489734
Status:
COMPLETED
Last Update Posted:
2021-08-19
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Extubation Delirium and End-tidal Sevoflurane Concentration
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '13818318679@139.com', 'phone': '021-18017591058', 'title': 'Dr. Xuan Wang', 'organization': "Children's Hospital of Fudan University"}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'First, the patients might have experienced pain in the PACU. However, distinguishing ED from pain in the PACU could be difficult.\n\nSecond, we did not observe the duration of each case of ED.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed and recorded during the PACU, an average of 1 hour.', 'description': 'In the PACU, any adverse events such as hypoxemia (defined as SpO2 \\<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.', 'eventGroups': [{'id': 'EG000', 'title': 'Low Concentration (LC)', 'description': 'In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 3, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Concentration (HC)', 'description': 'In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 5, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'respiratory obstruction', 'notes': 'Respiratory obstruction was defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'postoperative nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoxemia', 'notes': 'defined as SpO2 \\<92%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'laryngospasm', 'notes': 'defined as inability to ventilate despite maneuvers to relieve airway obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bronchospasm', 'notes': 'defined as wheezing on auscultation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Emergence Delirium (ED)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Concentration (LC)', 'description': 'In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.'}, {'id': 'OG001', 'title': 'High Concentration (HC)', 'description': 'In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '1.4', 'ciUpperLimit': '8.1', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 30 minutes after awakening', 'description': 'The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score \\>12. Higher score of PAED means a worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Concentration (LC)', 'description': 'low concentration group\n\nsevoflurane: extubation when end-tidal concentration of sevoflurane \\< 0.5%.'}, {'id': 'FG001', 'title': 'High Concentration (HC)', 'description': 'high concentration group\n\nSevoflurane: extubation when end-tidal concentration of sevoflurane \\>= 0.5%.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "From July 2015 to September 2015, 135 patients were assessed for eligibility in Children's Hospital of Fudan University.", 'preAssignmentDetails': 'Of 135 patients assessed for eligibility, 26 patients were excluded because they did not meet the inclusion criteria or declined to participate in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Concentration (LC)', 'description': 'In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.'}, {'id': 'BG001', 'title': 'High Concentration (HC)', 'description': 'In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '3.7', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '19.5', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '18.9', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'obtained from the hospital information system', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2015-06-16', 'resultsFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-27', 'studyFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Emergence Delirium (ED)', 'timeFrame': 'within 30 minutes after awakening', 'description': 'The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score \\>12. Higher score of PAED means a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sevoflurane', 'emergence delirium', 'preschool'], 'conditions': ['Delirium on Emergence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.', 'detailedDescription': 'Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine spray on vocal cord. After that, an effective caudal or brachial plexus block was performed. End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when extubating \\>=0.5%) and low concentration group (Group LC, end-tidal concentration of sevoflurane when extubating \\<0.5%). Patients in Group LC were extubated when they coughed or purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane \\>= 0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met: 1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in PACU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 2-7 years\n* ASA I - II\n* Estimated surgery time \\< 2 hours\n* Sevoflurane induction and maintenance along with caudal block or Axillary Block\n\nExclusion Criteria:\n\n* Craniofacial anomalies\n* Difficult exposure of the vocal cordS\n* Obesity\n* Asthma\n* Invalid caudal block or axillary block'}, 'identificationModule': {'nctId': 'NCT02489734', 'briefTitle': 'Post Extubation Delirium and End-tidal Sevoflurane Concentration', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Association Between Post Extubation Delirium and Pre-extubation End-tidal Sevoflurane Concentration in Children', 'orgStudyIdInfo': {'id': 'EDETSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low concentration (LC)', 'description': 'low concentration group', 'interventionNames': ['Drug: sevoflurane']}, {'type': 'EXPERIMENTAL', 'label': 'high concentration (HC)', 'description': 'high concentration group', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'sevoflurane', 'type': 'DRUG', 'description': 'extubation when end-tidal concentration of sevoflurane \\< 0.5%', 'armGroupLabels': ['low concentration (LC)']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'extubation when end-tidal concentration of sevoflurane \\>= 0.5%', 'armGroupLabels': ['high concentration (HC)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Xuan Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}