Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT03665792
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2018-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between Sevoflurane and qNOX
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-20', 'studyFirstSubmitDate': '2018-08-04', 'studyFirstSubmitQcDate': '2018-09-08', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sevoflurane application correlated with the qNOX index', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The sevoflurane application correlated with the qNOX index, meanwhile reflect the analgesia effect of sevoflurane application'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesic Adverse Reaction', 'Nociceptive Pain', 'Inhalation; Vapor']}, 'descriptionModule': {'briefSummary': 'This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the correlation between the sevoflurane and NOX index.', 'detailedDescription': 'This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the analgesia effect of the sevoflurane.\n\nAnd test the correlation between the sevoflurane and NOX index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'only elective thoracoscope surgery patients were enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Elective thoracoscope surgery patients\n2. Age ranging from 25 to 85 years\n3. American Society of Anesthesiologists (ASA) Physical Status score of 2 to 4\n4. a body mass index (BMI) ranging from 18.5 to 40 kg/m2.\n\nExclusion Criteria:\n\n1. Clinical diagnosis of Alzheimer's Disease\n2. implanted pacemaker\n3. Clinical diagnosis of psychiatric diseases\n4. Clinical diagnosis of epilepsy\n5. Clinical diagnosis of autonomic nervous system disorders which might affect the EEG"}, 'identificationModule': {'nctId': 'NCT03665792', 'briefTitle': 'The Correlation Between Sevoflurane and qNOX', 'organization': {'class': 'OTHER', 'fullName': 'China International Neuroscience Institution'}, 'officialTitle': 'The Prospective Observational Research of the Analgesic Effect of Sevoflurane and the Correlation Between Sevoflurane and qNOX', 'orgStudyIdInfo': {'id': 'CINI-ZYLX-201806-11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'nociception index qNOX', 'type': 'DEVICE', 'otherNames': ['CON , BIS'], 'description': 'non-invasive, real time, monitoring for nociception stimulation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Bei Liu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiaohua Wang, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China International Neuroscience Institution', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}