Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-03-05 @ 5:41 AM
Study NCT ID:
NCT03741361
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2018-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Anxiety or Depression on the Sedative Concentration of Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-10-11', 'releaseDate': '2019-09-23'}], 'estimatedResultsFirstSubmitDate': '2019-09-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073222', 'term': 'Patient Health Questionnaire'}], 'ancestors': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'An intravenous cannula was placed and 5 ml blood sample was drawn from each patient. The serum was separated and immediately stored at -80℃ for later analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-07', 'studyFirstSubmitDate': '2018-11-11', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect-site concentration (Ce) of propofol', 'timeFrame': 'Time of induction is less than 10 minutes.', 'description': 'Effect-site concentration (Ce) of propofol on the TCI-system at the sedative level of OAA/S score of 3, OAA/S score of 1, and OAA/S core of 1 and NI\\<64 reached will be recorded.'}], 'secondaryOutcomes': [{'measure': 'The induction dose of propofol', 'timeFrame': 'Time of induction is less than 10 minutes.', 'description': 'The dose of propofol required at the sedative level of OAA/S score of 3, OAA/S score of 1, and OAA/S core of 1 and NI\\<64 reached will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Female', 'Prospective Studies', 'Anesthetics, Intravenous', 'Propofol', 'Anxiety/*psychology', 'Depression/*psychology'], 'conditions': ['Anxiety', 'Depression', 'Propofol', 'Anesthetics, Intravenous']}, 'referencesModule': {'references': [{'pmid': '32445415', 'type': 'DERIVED', 'citation': 'Li RY, Lin M, Jiang HY, Wen SH, Shen JT, Huang WQ, Zhang XY. Impact of Anxiety or Depression Symptoms on Propofol Requirements for Sedation in Females: A Prospective Cohort Study. J Clin Pharmacol. 2020 Oct;60(10):1376-1384. doi: 10.1002/jcph.1631. Epub 2020 May 23.'}]}, 'descriptionModule': {'briefSummary': '120 consecutive female patients, 18-65 years old, American Society of Anesthesiologists (ASA) physical status I to II, scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this cohort study. The day before surgery, participants will be assessed the state of preoperative anxiety and depression. On the day of surgery, propofol will be administered by target controlled infusion (TCI) pump. During induction of anesthesia, the level of sedation will be evaluated. The induction dose of propofol, target effect-site concentration(Cet), plasma concentration(Cp) and effect-site concentration (Ce) of propofol will be recorded.', 'detailedDescription': "120 consecutive female patients, 18-65 years old, American Society of Anesthesiologists ( ASA) physical status I to II, scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this prospective cohort study. The day before surgery, participants were asked to complete the modified HADS questionnaire in an isolated calm room, and the score was used to assess the patients' anxiety and depression level in the past 6 months. On the day of surgery, propofol (Fresenius Kabi Austria GmbH, Graz, Austria)was administrated by using an intravenous target controlled infusion (TCI) pump (Alaris PK, Basingstoke, UK) with Schnider kinetic model. The initial effect-site concentration (Ce) was set as 1.0 μg/ml. After the TCI system displayed that Cp and Ce were at equilibrium, the target concentration of propofol was increased by an increment of 0.5 μg/ml until the patients achieved the three desired levels of sedation.The Ce and dose of propofol and the consuming time were recorded."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients, 18-65 years old, American Society of Anesthesiologists （ASA） physical status I or II, scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia in the first affiliated hospital of Sun Yat-sen University in Guangzhou, China will be recruited in this cohort study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* American Society of Anesthesiologists（ASA） physical status I or II\n* Body Mass Index(BMI) 18-25kg/m2\n* scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia.\n\nExclusion Criteria:\n\n* suffering from psychiatric diseases.\n* chronic use of anxiolytics, antidepressants, and sedative-hypnotics.\n* any sedative premedication.\n* a history of alcohol abuse.\n* allergy to propofol.\n* declining to participate and cooperate.'}, 'identificationModule': {'nctId': 'NCT03741361', 'briefTitle': 'The Impact of Anxiety or Depression on the Sedative Concentration of Propofol', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'The Impact of Anxiety or Depression on the Sedative Concentration of Propofol in Day-case Hysteroscopic Surgery: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'SYSU 2018-11-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anxiety and Depression', 'description': 'Female patients scheduled for hysteroscopic surgery under propofol-based intravenous anesthesia will be recruited in this prospective cohort study.', 'interventionNames': ['Other: anxiety and depression']}], 'interventions': [{'name': 'anxiety and depression', 'type': 'OTHER', 'description': 'Female patients who have a previous history of surgery or infertility, or a history of miscarriage or abortion are often susceptible to preoperative anxiety or depression. We will observe the effect of anxiety and depression on the dosage of propofol during induction.', 'armGroupLabels': ['Anxiety and Depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xuyu Zhang, M.D. and Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology,The first affiliated hospital of Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Starting 6 months after publication.', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuyu Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Xuyu Zhang', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-09-23', 'type': 'RELEASE'}, {'date': '2019-10-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Xuyu Zhang, Associate Professor, First Affiliated Hospital, Sun Yat-Sen University'}}}}