Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT05525104
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of DSA on Recovery of Anaesthesia in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'i.deheer@erasmusmc.nl', 'phone': '+31107040704', 'title': 'I.J. de Heer, MD', 'organization': 'Erasmus Medical center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The relatively large number of secondary exclusions due to protocol violations in the standard care group is a shortcoming of this study. The target number of 51 participants per study group was not achieved. Because this exclusion due to protocol violation is completely patient independent, confounding due to exclusion for an outcome-related reason is not an issue. So, to identify a treatment effect that would occur under optimal conditions, we choose to perform a per-protocol analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the entire study period: until the patiënt was discharged (on average 3-6 hours after anesthesia) or until the last Brice interview was conducted if the patient was 6 years or older (2 weeks after anesthesia).', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 3, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Decrease in blood pressure (-2 SD)', 'notes': 'A decrease in blood pressure (of -2 SD) that could be remedied with an intravenous fluid bolus which had no further consequences for the patient.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Prolonged hospitalisation', 'notes': 'The surgery was performed in day care, but the patient required longer hospitalization due to underlying disease (not related to anesthesia or study participation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Influence of DSA Monitoring on the Speed of Emergence.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '24.3'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '16.8'}]}]}], 'analyses': [{'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0', 'description': 'The speed of emergence is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the operating room are met (defined as a Steward score ≥ 3)\n\nThe Steward recovery score consists of three domains: consciousness, airway and motor. Consciousness can be scored from 0-2, in which 0 equals non responsive, 1 equals response to stimuli, 2 equals awake. Airway is scored from 0-2: airway that requires maintenance scores 0, maintaining good airway scores 1 and coughing on command or crying scores 2. Motor is also scored form 0-2: no movement scores 0, non-purposeful movement scores 1 and purposeful movement scores 2. Combining all three domains, the minimum score is 0 (unconscious) and the maximum score is 6 (completely awake) The speed of emergence is defined as a minimum score of 3, with a minimum score of 1 in each domain.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '40.5'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '32.5'}]}]}], 'analyses': [{'pValue': '0.066', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 0', 'description': 'The total time is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the recovery room are met (defined as a Steward score =6)\n\nThe Steward recovery score consists of three domains: consciousness, airway and motor. Consciousness can be scored from 0-2, in which 0 equals non responsive, 1 equals response to stimuli, 2 equals awake. Airway is scored from 0-2: airway that requires maintenance scores 0, maintaining good airway scores 1 and coughing on command or crying scores 2. Motor is also scored form 0-2: no movement scores 0, non-purposeful movement scores 1 and purposeful movement scores 2. Combining all three domains, the minimum score is 0 (unconscious) and the maximum score is 6 (completely awake).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Incidence of Postoperative Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': "The incidence of postoperative delirium is assessed with the Cornell assessment of postoperative delirium (is defined as a score equal to or greater than 9).\n\nThe Cornell assessment of postoperative delirium consists of eight questions. The first four questions are scored as follows: 0 equals always, 1 often, 2 sometimes, 3 rarely, 4 never.\n\n1. Does the child make eye contact with the caregiver?\n2. Are the child's actions purposeful?\n3. Is the child aware of his/her surroundings?\n4. Does the child communicatie needs and wants? In these first four questions, a higher score represents a worse outcome.\n\n The last four questions are scored as follows: 0 equals never, 1 rarely, 2 sometimes, 3 often and 4 always.\n5. Is the child restless?\n6. Is the child inconsolable?\n7. Is the child underactive - very little movement while awake?\n8. Does it take the child a long time to respond to interactions? In these last four questions, a higher score represents a worse outcome.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration'}], 'classes': [{'categories': [{'title': 'DSA pattern representing general anesthesia', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'DSA pattern representing too deep anesthesia', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'DSA pattern representing lighter anesthesia', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'Density spectral array patterns will be saved, and divided into categories, which will be compared between the two study groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Recall of Events During the Procedure (Awareness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0, Day 1, Day 14', 'description': 'Awareness is assessed with a modified Brice interview in children of 6 years or older.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Interviews only conducted in children ≥6 years'}, {'type': 'SECONDARY', 'title': 'The End-tidal Sevoflurane Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'id': 'OG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'The mean end-tidal sevoflurane concentration measured during surgical procedure', 'unitOfMeasure': 'percentage sevoflurane of exhaled air', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'id': 'FG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Failed caudal analgesia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Premedication needed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Cancelled operation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'id': 'BG001', 'title': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend\n\nNarcotrend Monitor (MT MonitorTechnik, Hannover, Germany): This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '88', '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.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '13.8', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '13.7', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ASA-score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': '1', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The ASA classification is a system to assess and communicate a patient's pre-anesthesia medical co-morbidities. It ranges from 1 to 6. An ASA-classification of 1 equals a healthy patient, 2 equals mild systemic disease (e.g. asthma without exacerbation) and 3 severe systemic disease (e.g. asthma with exacerbation). Along with other risk factors, it can be used to predict perioperative risks.", 'unitOfMeasure': 'Participants'}, {'title': 'Type of surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Orchidopexy', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Inguinal hernia repair', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Urethral valves repair', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Hypospadias correction', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Cystoscopy/Sachse or meatotomy', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Other urological', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Orthopedic surgery', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of general anesthesia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '83.7', 'spread': '39.1', 'groupId': 'BG000'}, {'value': '69.4', 'spread': '37.2', 'groupId': 'BG001'}, {'value': '75.5', 'spread': '36.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-14', 'size': 1257256, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-21T09:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and parents will be blinded to the treatment. The outcome assessor will be blinded as well.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2022-08-30', 'resultsFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-05', 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Influence of DSA Monitoring on the Speed of Emergence.', 'timeFrame': 'Day 0', 'description': 'The speed of emergence is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the operating room are met (defined as a Steward score ≥ 3)\n\nThe Steward recovery score consists of three domains: consciousness, airway and motor. Consciousness can be scored from 0-2, in which 0 equals non responsive, 1 equals response to stimuli, 2 equals awake. Airway is scored from 0-2: airway that requires maintenance scores 0, maintaining good airway scores 1 and coughing on command or crying scores 2. Motor is also scored form 0-2: no movement scores 0, non-purposeful movement scores 1 and purposeful movement scores 2. Combining all three domains, the minimum score is 0 (unconscious) and the maximum score is 6 (completely awake) The speed of emergence is defined as a minimum score of 3, with a minimum score of 1 in each domain.'}], 'secondaryOutcomes': [{'measure': 'Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.', 'timeFrame': 'Day 0', 'description': 'The total time is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the recovery room are met (defined as a Steward score =6)\n\nThe Steward recovery score consists of three domains: consciousness, airway and motor. Consciousness can be scored from 0-2, in which 0 equals non responsive, 1 equals response to stimuli, 2 equals awake. Airway is scored from 0-2: airway that requires maintenance scores 0, maintaining good airway scores 1 and coughing on command or crying scores 2. Motor is also scored form 0-2: no movement scores 0, non-purposeful movement scores 1 and purposeful movement scores 2. Combining all three domains, the minimum score is 0 (unconscious) and the maximum score is 6 (completely awake).'}, {'measure': 'The Incidence of Postoperative Delirium', 'timeFrame': 'Day 0', 'description': "The incidence of postoperative delirium is assessed with the Cornell assessment of postoperative delirium (is defined as a score equal to or greater than 9).\n\nThe Cornell assessment of postoperative delirium consists of eight questions. The first four questions are scored as follows: 0 equals always, 1 often, 2 sometimes, 3 rarely, 4 never.\n\n1. Does the child make eye contact with the caregiver?\n2. Are the child's actions purposeful?\n3. Is the child aware of his/her surroundings?\n4. Does the child communicatie needs and wants? In these first four questions, a higher score represents a worse outcome.\n\n The last four questions are scored as follows: 0 equals never, 1 rarely, 2 sometimes, 3 often and 4 always.\n5. Is the child restless?\n6. Is the child inconsolable?\n7. Is the child underactive - very little movement while awake?\n8. Does it take the child a long time to respond to interactions? In these last four questions, a higher score represents a worse outcome."}, {'measure': 'Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.', 'timeFrame': 'Day 0', 'description': 'Density spectral array patterns will be saved, and divided into categories, which will be compared between the two study groups.'}, {'measure': 'Incidence of Recall of Events During the Procedure (Awareness)', 'timeFrame': 'Day 0, Day 1, Day 14', 'description': 'Awareness is assessed with a modified Brice interview in children of 6 years or older.'}, {'measure': 'The End-tidal Sevoflurane Concentration', 'timeFrame': 'Day 0', 'description': 'The mean end-tidal sevoflurane concentration measured during surgical procedure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Density spectral array', 'Depth of hypnosis', 'Paediatric anaesthesia'], 'conditions': ['Anesthesia', 'Depth of Hypnosis Monitoring']}, 'referencesModule': {'references': [{'pmid': '39803999', 'type': 'DERIVED', 'citation': 'de Heer IJ, Raab HAC, de Vries J, Karaoz-Bulut G, Weber F. The Influence of Electroencephalographic Density Spectral Array Guidance of Sevoflurane Administration on Recovery From General Anesthesia in Children. A Randomized Controlled Trial. Paediatr Anaesth. 2025 Apr;35(4):287-293. doi: 10.1111/pan.15065. Epub 2025 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'In this randomised, blinded study, we will investigate the influence of DSA on recovery from general anaesthesia. DSA monitoring provides continuous information on depth of hypnosis. Based on DSA monitoring dose adjustments of sevoflurane can be made. We expect that this will lead to a faster speed of emergence and recovery.', 'detailedDescription': 'Electroencephalographic density spectral array (DSA) is a three dimensional method to display electroencephalogram (EEG) signals consisting of the EEG frequency (y-axis), the power of the EEG signal (colour-coded to be integrated into a two dimensional plot) and the development of the EEG power spectrum over time (x-axis). DSA is routinely used to measure depth of hypnosis (DoH) by a part of the staff members in our department. When DSA is used, dose adjustments of sevoflurane will be made based on monitoring depth of anaesthesia. However, most of our colleague do not use DSA. Dose adjustment is then based on (subjective) clinical surrogate parameters, or in general mostly based on a minimal alveolar concentration of the anaesthetic gas that is used.\n\nElectroencephalographic DSA monitoring provides continuous objective information on DoH and should result in a faster speed of emergence and recovery from general anaesthesia (GA). This will be addressed in a randomised controlled trial.\n\nIn patients randomised to the intervention group, the anaesthetic agent sevoflurane will be administered on the basis of objective measures of anaesthetic depth, the typical DSA pattern for GA. We expect a significantly faster speed of emergence and recovery in the intervention group based on clinical experience. The Narcotrend monitor is validated for use in paediatric patients. There are thus no additional risk factors apart from those, which are inherent with general anaesthesia. Patient randomised to the control group will receive standard treatment, that is delivery of sevoflurane based on a MAC of 0.9 respectively an end tidal sevoflurane concentration of 2.3%. A non-invasive therapeutical intervention (DSA based conduct of GA) should result in the advantage of faster recovery, without any additional risk factor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent of parents/guardians\n* Age ≥6 months and ≤12 years\n* Surgical procedure requiring GA supplemented with caudal analgesia\n* Ability of the parents/guardians to communicate in Dutch\n\nExclusion Criteria:\n\n* Primary exclusion criteria\n* Withdrawal of informed consent\n* (Chronic) use of drugs influencing the electroencephalogram\n* Use of premedication\n* Known intolerance for sevoflurane\n* Parents/guardians unable to communicate in Dutch\n* Secondary exclusion criteria\n* Protocol violation\n* Data registration failure'}, 'identificationModule': {'nctId': 'NCT05525104', 'acronym': 'DSA-RCT-1', 'briefTitle': 'The Effect of DSA on Recovery of Anaesthesia in Children', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'The Influence of Electroencephalographic Density Spectral Array Guidance of Sevoflurane Administration on Recovery From General Anaesthesia in Children Between 6 Months and 12 Years.', 'orgStudyIdInfo': {'id': 'DSA-RCT-1'}, 'secondaryIdInfos': [{'id': 'NL80282.078.22', 'type': 'OTHER', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend', 'interventionNames': ['Device: Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)']}], 'interventions': [{'name': 'Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany)', 'type': 'DEVICE', 'description': 'This trial is designed to investigate the additional value of Density Spectral Array monitoring, on the "speed of emergence" after general anaesthesia. We will compare traditional general anaesthesia with sevoflurane using a MAC value and subjective clinical parameters to the objective and continuous approach using DSA depth of hypnosis. The investigational product is the validated Narcotrend monitor, an electroencephalographic monitor, that is regularly used in anaesthesia practice in the Sophia children\'s hospital and will be used according to intended purpose. The extended version as used in the operating room in the Sophia Children\'s hospital offers a diversity of diagrams including Density Spectral Array.\n\nThe electroencephalographic Narcotrend monitor records frontal EEG-activity. Standard paediatric ECG electrodes are used for EEG registration', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Frank Weber, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will become available after data collection has been completed.', 'ipdSharing': 'YES', 'description': "Data of a patient will only be shared with other fellow researchers (e.g. in case of follow-up studies) upon reasonable request, on the condition that the child's parent explicitly consented.", 'accessCriteria': 'Reasonable request of fellow researches and only data of patients after explicit consent from parents on the ICF.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BSc', 'investigatorFullName': 'Hannah Raab', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}