[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385793":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":35,"studyPopulation":22,"armGroups":36,"interventions":49,"overallOfficials":22,"centralContacts":22,"locations":57,"responsibleParty":78,"collaborators":22,"id":82,"slug":22,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":22,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":60,"whyStopped":22,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"China Medical University, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Montgomery-asberg Depression Rating Scale score","Changes of Montgomery-asberg Depression Rating Scale score","from baseline to postoperative 24 hours",[14,18],{"measure":15,"description":16,"timeFrame":17},"Bispectral index","Changes of bispectral index data","from 8pm to 6am on the first postoperative night",{"measure":19,"description":20,"timeFrame":21},"Gut microbiota","changs of gut microbiota","from baseline to postoperative 72 hours",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":22,"timePerspective":22,"maskingInfo":28},"RANDOMIZED","PARALLEL","Parallel Assignment","TREATMENT",{"masking":29,"maskingDescription":22,"whoMasked":30},"QUADRUPLE",[31,32,33,34],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","For female patients, breast cancer patients have a high risk of developing depression, and approximately 20%-45% of breast cancer patients suffer from postoperative depression. Esketamine is an anesthetic in analgesia, and has presently become more and more popular for treating anti-depression, particularly for resistant depression.\n\nThis study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Control","PLACEBO_COMPARATOR","All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.",[42],"Drug: Saline Solution",{"label":44,"type":45,"description":46,"interventionNames":47},"Esketamine","ACTIVE_COMPARATOR","All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine.",[48],"Drug: Esketamine",[50,54],{"type":51,"name":44,"description":52,"armGroupLabels":53,"otherNames":22},"DRUG","All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg\u002Fkg.",[44],{"type":51,"name":55,"description":40,"armGroupLabels":56,"otherNames":22},"Saline Solution",[38],[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"the First Hospital of China Medical University","RECRUITING","Shenyang","Liaoning","110001","China","CN",{"type":67,"coordinates":68},"Point",[69,70],123.43278,41.79222,{"lat":70,"lon":69},[73],{"name":74,"role":75,"phone":76,"phoneExt":22,"email":77},"Wen-fei Tan, M.D.,Ph.D","CONTACT","024-83283100","winfieldtan@hotmail.com",{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Wenfei Tan","Professor","100385793",false,"NCT04303325","Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)","ESPOD-BI","Inclusion Criteria:\n\n* At least18 years and pre-menopausal;\n* scheduled to undergo elective breast cancer operation;\n* American Society of Anaesthesiologists (ASA) risk classification I-II.\n* Montgomery-asberg Depression Rating Scale (MADRS) score ≥22\n\nExclusion Criteria:\n\n* Cognitive difficulties\n* Partial or complete gastrectomy\n* Previous esophageal surgery\n* Inability to conform to the study's requirements\n* Ongoing participation or participation in another study \\\u003C1 month ago","FEMALE","18 Years","65 Years",{"count":92,"type":93},72,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline.",[99],"Depression",[101,102,103,104],"depression","sleep deprivation","gut microbiota","bispectral index","2024-07-18",{"date":107,"type":108},"2024-07-22","ACTUAL",{"date":110,"type":108},"2021-10-08",{"date":112,"type":93},"2024-12-30",{"name":5,"class":6},1]