Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-29 @ 1:42 AM
Study NCT ID:
NCT04292457
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2020-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Namsos Anaesthesia Children Outcome Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 761}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2020-02-29', 'studyFirstSubmitQcDate': '2020-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Anesthesia Emergence Delirium Scale (PAED) ≥ 10', 'timeFrame': '1 hour', 'description': 'A PAED score ≥ 10 during the first hour after emergence from anaesthesia is defined as an ED event occuring'}], 'secondaryOutcomes': [{'measure': 'Face, Legs, Activity, Cry, Consolability Scale (FLACC) ≥ 4', 'timeFrame': '1 hour', 'description': 'A FLACC score ≥ 4 during the first hour after emergence from anaesthesia is defined as moderate or severe pain'}, {'measure': 'Post Hospital Behavioral Questionnaire (PHBQ)', 'timeFrame': '7 days', 'description': 'An average score \\> 3 in one or more of the questionnaire categories is defined as postoperative behavioural change'}, {'measure': 'Post Hospital Behavioral Questionnaire (PHBQ)', 'timeFrame': '30 days', 'description': 'An average score \\> 3 in one or more of the questionnaire categories is defined as postoperative behavioural change'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric Anaesthesia', 'Emergence Delirium', 'Postoperative Behavioral Changes', 'Sevoflurane', 'Propofol', 'Adenotonsillectomy'], 'conditions': ['Emergence Delirium']}, 'descriptionModule': {'briefSummary': "Behavioral disturbances are often seen in children after anesthesia both immediately after surgery (emergence delirium) and after discharge from hospital. Persisting behavioral changes may affect emotional and cognitive development. It is known that both type of surgery and anesthetic management affect the occurrence of behavioral disturbances. Specifically, differences in occurrence were found after sevoflurane anesthesia and propofol anesthesia, two anesthetics that are generally used in practice. However, evidence is based on methodologically weak studies.\n\nThe described occurrence of behavioral disturbances in children after anesthesia is not in line with the investigators' clinical experience, and neither are the described differences in occurrence between sevoflurane anesthesia and propofol anesthesia. This study will compare emergence delirium and behavioral changes after discharge from hospital in children who had surgery for removal of their tonsils under sevoflurane anesthesia versus propofol anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adenotomy and/or tonsillotomy and/or tonsillectomy\n* ASA physical status class I or II\n\nExclusion Criteria:\n\n* unexperienced ear-nose-throat (ENT) surgeon (ENT surgeon \\< 1 year of training, ENT surgeon without experience with the use of laryngeal mask as airway during adenotomy/tonsillotomy/tonsillectomy)\n* preoperative syndromes\n* ASA physical status class \\> 2\n* missing written consent from parents/guardians'}, 'identificationModule': {'nctId': 'NCT04292457', 'acronym': 'NACOS', 'briefTitle': 'Namsos Anaesthesia Children Outcome Study', 'organization': {'class': 'OTHER', 'fullName': 'Helse Nord-Trøndelag HF'}, 'officialTitle': 'Namsos Anaesthesia Children Outcome Study (NACOS)', 'orgStudyIdInfo': {'id': '43654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol', 'description': 'Anesthesia is maintained with Propofol', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Sevoflurane', 'description': 'Anesthesia is maintained with Sevoflurane', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'Anesthesia is maintained with a continuous infusion of Propofol. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.', 'armGroupLabels': ['Propofol']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.', 'armGroupLabels': ['Sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7800', 'city': 'Namsos', 'state': 'Trøndelag', 'country': 'Norway', 'facility': 'Namsos Hospital, Nord-Trondelag Hospital Trust', 'geoPoint': {'lat': 64.46624, 'lon': 11.49572}}, {'city': 'Trondheim', 'state': 'Trøndelag', 'country': 'Norway', 'facility': 'ØNH Legen', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Hallvard Græslie, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of surgical Clinic, Namsos Hospital, Nord-Trondelag Hospital Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'ØNH Legen Trondheim', 'class': 'UNKNOWN'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}