[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637701":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":57,"centralContacts":61,"locations":72,"responsibleParty":155,"collaborators":158,"id":167,"slug":168,"hasResults":169,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":66,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":175,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":66,"studyType":181,"phases":182,"briefSummary":184,"conditions":185,"keywords":192,"overallStatus":196,"whyStopped":66,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Dex-Esk + active tDCS","EXPERIMENTAL","Participants will receive dexmedetomidine-esketamine (Dex-Esk) combination and active transcranial direct current stimulation (tDCS).",[13,14],"Drug: Dex-Esk","Device: Active tDCS",{"label":16,"type":10,"description":17,"interventionNames":18},"Dex-Esk + sham tDCS","Participants will receive dexmedetomidine-esketamine (Dex-Esk) combination and sham (placebo) transcranial direct current stimulation (tDCS).",[13,19],"Device: Sham tDCS",{"label":21,"type":10,"description":22,"interventionNames":23},"Placebo + active tDCS","Participants will receive placebo (normal saline) and active transcranial direct current stimulation (tDCS).",[24,14],"Drug: Placebo",{"label":26,"type":27,"description":28,"interventionNames":29},"Placebo + sham tDCS","PLACEBO_COMPARATOR","Participants will receive placebo (normal saline) and sham (placebo) transcranial direct current stimulation (tDCS).",[24,19],[31,38,44,51],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Dex-Esk","Dexmedetomidine-esketamine combination (1 μg\u002FmL dexmedetomidine and 0.5 mg\u002FmL esketamine) will be administered after anesthesia induction, firstly as a loading dose at a rate of \\[0.4 x body weight (kg)\\] mL\u002Fh for 30 minutes (0.2 μg\u002Fkg dexmedetomidine and 0.1 mg\u002Fkg esketamine), followed by a maintenance infusion at a rate of \\[0.1 x body weight (kg)\\] mL\u002Fh (0.1 μg\u002Fkg\u002Fh dexmedetomidine and 0.05 mg\u002Fkg\u002Fh esketamine) until one hour before the expected end of surgery.\n\nPostoperative patient-controlled analgesia will be established with a 100 mL mixture (containing 1.0 μg\u002FmL sufentanil, 1.25 μg\u002FmL dexmedetomidine, and 0.25 mg\u002FmL esketamine in normal saline), programmed to deliver 2-mL boluses with an 8-minute lockout interval and an 1-mL\u002Fh background infusion, and provided for 48 hours (at least 24 hours).",[9,16],[37],"Dexmedetomidine-esketamine combination",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Placebo","Placebo (normal saline) will be administered after anesthesia induction, firstly as a loading dose at a rate of \\[0.4 x body weight (kg)\\] mL\u002Fh for 30 minutes, followed by a maintenance infusion at a rate of \\[0.1 x body weight (kg)\\] mL\u002Fh until one hour before the expected end of surgery.\n\nPostoperative patient-controlled analgesia will be established with a 100 mL mixture (containing 1.0 μg\u002FmL sufentanil in normal saline), programmed to deliver 2-mL boluses with an 8-minute lockout interval and an 1-mL\u002Fh background infusion, and provided for 48 hours (at least 24 hours).",[21,26],[43],"Normal saline",{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DEVICE","Active tDCS","Active transcranial direct current stimulation (tDCS) will be administered using a battery-powered stimulator. The anode will be positioned over the left dorsolateral prefrontal cortex (DLPFC, F3) and the cathode over the right supraorbital region (Fp2). The stimulation intensity will be set at 2.0 mA, featuring a 30-second linear ramp-up at the beginning and a 30-second ramp-down at the end of each session.\n\nEach participant will receive a total of three 20-minute sessions of active tDCS. The first session will be provided at 40 minutes after extubation in the post-anesthesia care unit. Two other sessions will be provided on postoperative days 1 and 2 (between 10:00 and 12:00 am).",[9,21],[50],"Active transcranial direct current stimulation",{"type":45,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Sham tDCS","Sham transcranial direct current stimulation (tDCS) will be administered using a battery-powered stimulator. The anode will be positioned over the left dorsolateral prefrontal cortex (DLPFC, F3) and the cathode over the right supraorbital region (Fp2). To ensure blinding, the device will deliver a initial 30-second ramp-up to 2.0 mA followed immediately by a 30-second ramp-down to 0 mA. The device remains \"ON\" for the remaining 19 minutes with no effective current output, mimicking the peripheral scalp sensation without delivering cortical modulation.\n\nEach participant will receive a total of three 20-minute sessions of sham tDCS. The first session will be provided at 40 minutes after extubation in the post-anesthesia care unit. Two other sessions will be provided on postoperative days 1 and 2 (between 10:00 and 12:00 am).",[16,26],[56],"Sham transcranial direct current stimulation",[58],{"name":59,"affiliation":5,"role":60},"Dong-Xin Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[62,68],{"name":63,"role":64,"phone":65,"phoneExt":66,"email":67},"Dong-Xin Wang, MD, PHD","CONTACT","86 10 83572784",null,"wangdongxin@hotmail.com",{"name":69,"role":64,"phone":70,"phoneExt":66,"email":71},"Zhen-Zhen Xu, MD","86 10 83572460","zjxvzhenzhen@126.com",[73,89,103,117,131,145],{"facility":5,"status":66,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Beijing","Beijing Municipality","100034","China","CN",{"type":80,"coordinates":81},"Point",[82,83],116.39723,39.9075,{"lat":83,"lon":82},[86,88],{"name":59,"role":64,"phone":87,"phoneExt":66,"email":67},"+86 10 83572784",{"name":69,"role":64,"phone":70,"phoneExt":66,"email":71},{"facility":90,"status":66,"city":91,"state":92,"zip":93,"country":77,"countryCode":78,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Fujian Medical University Union Hospital","Fuzhou","Fujian","362011",{"type":80,"coordinates":95},[96,97],119.30611,26.06139,{"lat":97,"lon":96},[100],{"name":101,"role":64,"phone":66,"phoneExt":66,"email":102},"Dan-Feng Zhang, MD","mazui1234@163.com",{"facility":104,"status":66,"city":105,"state":106,"zip":107,"country":77,"countryCode":78,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Peking University Shenzhen Hospital","Shenzhen","Guangdong","518036",{"type":80,"coordinates":109},[110,111],114.0683,22.54554,{"lat":111,"lon":110},[114],{"name":115,"role":64,"phone":66,"phoneExt":66,"email":116},"Tao Luo, MD","496855048@qq.com",{"facility":118,"status":66,"city":119,"state":120,"zip":121,"country":77,"countryCode":78,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Xijing Hospital, Air Force Medical University","Xi'an","Shaanxi","710032",{"type":80,"coordinates":123},[124,125],108.92861,34.25833,{"lat":125,"lon":124},[128],{"name":129,"role":64,"phone":66,"phoneExt":66,"email":130},"Zhi-Hong Lu, MD","deerlu23@163.com",{"facility":132,"status":66,"city":133,"state":134,"zip":135,"country":77,"countryCode":78,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"First Affilited Hospital, School of Medicine, Zhejiang University","Hangzhou","Zhejiang","310006",{"type":80,"coordinates":137},[138,139],120.16142,30.29365,{"lat":139,"lon":138},[142],{"name":143,"role":64,"phone":66,"phoneExt":66,"email":144},"Dian-San Su, MD","diansansu@yahoo.com",{"facility":146,"status":66,"city":133,"state":134,"zip":147,"country":77,"countryCode":78,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"Second Affilited Hospital, School of Medicine, Zhejiang University","310009",{"type":80,"coordinates":149},[138,139],{"lat":139,"lon":138},[152],{"name":153,"role":64,"phone":66,"phoneExt":66,"email":154},"Min Yan, MD","zryanmin@zju.edu.cn",{"type":60,"investigatorFullName":156,"investigatorTitle":157,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"Dong-Xin Wang","Professor",[159,160,162,164,166],{"name":104,"class":6},{"name":161,"class":6},"The First Affiliated Hospital of Air Force Medicial University",{"name":163,"class":6},"Zhejiang University",{"name":165,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":90,"class":6},"100637701","phase-4-dexmedetomidine-esketamine-and-tdcs-for-prevention-of-neurocognitive-complications-after-surgery-100637701",false,"NCT07576517","Dexmedetomidine-esketamine and tDCS for Prevention of Neurocognitive Complications After Surgery","Perioperative Use of Dexmedetomidine-esketamine Combination and Transcranial Direct Current Stimulation for Prevention of Neurocognitive Complications in Older Patients After Non-cardiac Surgery: a 2×2 Factorial Trial","Inclusion Criteria:\n\n* Aged 65 to 90 years;\n* Preoperative Mini-Mental State Examination (MMSE) score \\\u003C 27 points, indicating possible cognitive impairment ranging from mild to moderate;\n* Scheduled to undergo elective non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration \\> 1 hour;\n* Required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n* Preoperative inability to communicate due to coma, severe dementia, end-stage disease, or language impairment;\n* History of schizophrenia, epilepsy, Parkinson's disease, brain trauma\u002Fsurgery, or myasthenia gravis;\n* Presence of metal implants in the intracranial or cervical region (such as cochlear implants, aneurysm clips, deep brain stimulation electrodes), or skin damage or severe skin disease on the head;\n* Severe cardiac dysfunction (left ventricular ejection fraction \\\u003C 30%), comorbid with sick sinus syndrome, severe bradycardia (heart rate \\\u003C 50 bpm), or second-degree or higher atrioventricular block, or implantation of a cardiac pacemaker;\n* Uncontrolled hyperthyroidism or pheochromocytoma;\n* Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis), or ASA classification ≥ IV;\n* Allergy to dexmedetomidine or esketamine;\n* Participation in other clinical studies within the past 3 months;\n* Other conditions that are deemed unsuitable for study participation.",true,"ALL","65 Years","90 Years",{"count":179,"type":180},1160,"ESTIMATED","INTERVENTIONAL",[183],"PHASE4","Neurocognitive complications, mainly delirium and neurocognitive disorders, are common cerebral complications in older patients after surgery and associated with worse outcomes. In previous studies, perioperative use of dexmedetomidine-esketamine combination improved analgesia and sleep quality after surgery. Perioperative use of transcranial direct current stimulation (tDCS) also improved sleep quality and reduced delirium occurrence early after surgery. This 2×2 factorial trial is designed to investigate the effects of perioperative dexmedetomidine-esketamine combination and tDCS on early postoperative neurocognitive recovery and delirium occurrence in older patients.",[186,187,188,189,190,191],"Older Patients","Surgery","Dexmedetomidine","Esketamine","Transcranial Direct Current Stimulation","Perioperative Neurocognitive Disorders",[193,187,188,189,194,195],"Older patients","Transcranial direct current stimulation","Perioperative neurocognitive disorders","NOT_YET_RECRUITING","2026-05-07",{"date":199,"type":200},"2026-05-12","ACTUAL",{"date":202,"type":180},"2026-06",{"date":204,"type":180},"2030-06",{"name":5,"class":6},6]