Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02440269
Status:
UNKNOWN
Last Update Posted:
2015-05-12
First Post:
2015-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Circadian Rhythms on Norctrend Index in Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-08', 'studyFirstSubmitDate': '2015-05-03', 'studyFirstSubmitQcDate': '2015-05-08', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'narcotrend index', 'timeFrame': 'during operation time', 'description': 'the narcotrend index we recorded during the surgery and anesthesia in appropriate depth of anesthesia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Patients Needed Surgery and Anesthesia', 'Except on the Head or Facial Surgery']}, 'referencesModule': {'references': [{'pmid': '34488646', 'type': 'DERIVED', 'citation': 'Shen JH, Ye M, Chen Q, Chen Y, Zhao HL, Khan A, Yi B, Ning JL, Lu KZ, Gu JT. Effects of circadian rhythm on Narcotrend index and target-controlled infusion concentration of propofol anesthesia. BMC Anesthesiol. 2021 Sep 6;21(1):215. doi: 10.1186/s12871-021-01445-z.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the Circadian Rhythms effects on the Norctrend Index in Anesthesia.', 'detailedDescription': "It has been reported that circadian rhythm has many aspects of influence on human body. But little is knew about the circadian rhythm affect on Narcotrend index (made in Germany) in total intravenous anesthesia .The investigators' study is to find the relationship between them."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who receive surgery and general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ;\n* ability to compliance the research plan;\n* volunteered and signed for the study ;\n* receive surgery and general anesthesia\n\nExclusion Criteria:\n\n* ASA\\>Ⅱ;\n* Head or facial surgery\n* can't collaborate;"}, 'identificationModule': {'nctId': 'NCT02440269', 'briefTitle': 'The Effect of Circadian Rhythms on Norctrend Index in Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'orgStudyIdInfo': {'id': 'narcotrend'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A：day', 'description': 'the patients who receive surgery and anesthesia during 8:00 am to 6:00 pm'}, {'label': 'B：night', 'description': 'the patients who receive surgery and anesthesia during 10:00 pm to 5:00 am next day'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'lu kai zhi, phd', 'role': 'CONTACT', 'email': '304365565@qq.com', 'phone': '+8613637962143'}], 'facility': 'Department of Anesthesiology, Southwest Hospital Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'lu kai zhi, phd', 'role': 'CONTACT', 'email': '304365565@qq.com', 'phone': '+8613697962143'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lu KZ', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Head of anesthesiology, Southwest Hospital', 'investigatorFullName': 'Lu KZ', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}