[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572178":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":46,"centralContacts":51,"locations":32,"responsibleParty":61,"collaborators":32,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":32,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":90,"whyStopped":32,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":32},{"fullName":5,"class":6},"Guangzhou General Hospital of Guangzhou Military Command","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjusted-group","EXPERIMENTAL","After administering esketamine at low dose , this group adjusted drug dosage under closed-loop control based on the new BIS baseline(50＋N).",[13,14],"Drug: Esketamine at low dose","Device: new BIS baseline",{"label":16,"type":10,"description":17,"interventionNames":18},"Non-adjusted group","After administering esketamine at low dose, this group adjusted drug dosage under closed-loop control based on the original BIS baseline(50).",[13,19],"Device: original BIS baseline",{"label":21,"type":22,"description":23,"interventionNames":24},"control group","PLACEBO_COMPARATOR","This group adjusted drug dosage under closed-loop control based on the original BIS baseline(50) with an equivalent volume of saline.",[25,19],"Drug: an equivalent dose of saline",[27,33,38,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Esketamine at low dose","Esketamine at low dose was administered(0.2mg· kg-1, 5 ug· kg-1 continuous infusion) and drug dosage was adjusted(propofol and remifentanil) based on the new BIS baseline ( calculated from the pilot study).",[9,16],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"DEVICE","new BIS baseline","Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.",[9],{"type":28,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"an equivalent dose of saline","An equivalent dose of saline was given and closed-loop control stared.",[21],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":32},"original BIS baseline","Drug dosage was adjused under close-loop control based on original BIS baseline.",[16,21],[47],{"name":48,"affiliation":49,"role":50},"BO xu, doctor, chief director","department of anesthesiology, southern theater general hospital of PLA, Guangzhou, China.","STUDY_DIRECTOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":32,"email":56},"xiaoshan Li, postgraduate","CONTACT","86 + 17820686302","1225564331@qq.com",{"name":58,"role":54,"phone":59,"phoneExt":32,"email":60},"bo Xu, Doctor, chief director.","86 + 13802738125","xubo333@hotmail.com",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","bo xu","Doctor; Chief director.","100572178","phase-4-feasibility-of-closed-loop-tci-based-on-new-eeg-baseline-in-the-presence-of-low-dose-of-esketamine-100572178",false,"NCT06729892","Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine","Feasibility of Closed-loop TCI Based on New BIS Baseline in the Presence of Low Dose of Esketamine: a Randomized Controlled Equivalence Trial.","Inclusion Criteria:\n\n* BMI 18\\~27kg· m-2;\n* American Society of Anesthesiologists (ASA)physical status I\\~II;\n* Undergoing elective laparoscopic surgery.\n\nExclusion Criteria:\n\n* Known or suspected neurological diseases, tumors, stroke, degenerative neurological diseases, epileptic seizures, serious head injuries, cognitive disorders, post-traumatic stress disorder, mental illnesses, severe depression, psychosis, etc.;\n* Contraindications to ketamine, propofol or remifentanil;\n* Use of psychotropic drugs within the past 7 days;\n* History of drug abuse or drug addiction within the past 30 days or during pregnancy;\n* Current participation in any other studies involving other drugs or devices.","ALL","18 Years","55 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The propofol-remifentanil closed-loop TCI system based on EEG guidance has been clinically verified, which enables more precise anesthetic dosing. As an adjunct to anesthesia, esketamine has been shown to stabilize hemodynamics, reduce opioid use, and reduce postoperative nausea and vomiting. However, due to its specific electroencephalographic excitatory effect, esketmine's clinical use in close-loop system has been limited. The aim of this experiment was to determine the specific impact of esketamine on EEG and thus obtain a new EEG baseline for close-loop system, which can broaden the application of close-loop TCI system in combination with other drugs.",[83,84],"General Anesthesia With Propofol","Closed-Loop",[86,87,88,89],"eskemine","close-loop TCI","EEG","depth of anesthesia","NOT_YET_RECRUITING","2025-01-09",{"date":93,"type":94},"2025-01-13","ACTUAL",{"date":96,"type":77},"2025-01-20",{"date":98,"type":77},"2025-05-30",{"name":63,"class":6}]