[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633180":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":53,"locations":62,"responsibleParty":91,"collaborators":94,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":57,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":57,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":120,"overallStatus":125,"whyStopped":57,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Esketamine dose 1","EXPERIMENTAL","During anesthesia, a loading dose esketamine (0.5 mg\u002Fml) 0.4 ml\u002Fkg will be infused over 30 minutes (0.1 mg\u002Fkg) after anesthesia induction, followed by a continuous infusion at 0.1 ml\u002Fkg\u002Fh (0.05 mg\u002Fkg\u002Fh) until 1 hour before the expected end of surgery.\n\nAfter surgery, patient-controlled intravenous analgesia will be established with esketamine (0.25 mg\u002Fml) and sufentanil (1 ug\u002Fml), programmed to deliver 2-ml bolus (0.5 mg esketamine) with a 8-10-minute lock-out time and a 1-ml\u002Fh (0.25 mg\u002Fh esketamine) background infusion, and used for up to 48 hours.",[13],"Drug: Esketamine 1",{"label":15,"type":10,"description":16,"interventionNames":17},"Esketamine dose 2","During anesthesia, a loading dose esketamine (1 mg\u002Fml) 0.4 ml\u002Fkg will be infused over 30 minutes (0.2 mg\u002Fkg) after anesthesia induction, followed by a continuous infusion at 0.1 ml\u002Fkg\u002Fh (0.1 mg\u002Fkg\u002Fh) until 1 hour before the expected end of surgery.\n\nAfter surgery, patient-controlled intravenous analgesia will be established with esketamine (0.5 mg\u002Fml) and sufentanil (1 ug\u002Fml), programmed to deliver 2-ml bolus (1 mg esketamine) with a 8-10-minute lock-out time and a 1-ml\u002Fh (0.5 mg\u002Fh esketamine) background infusion, and used for up to 48 hours.",[18],"Drug: Esketamine 2",{"label":20,"type":10,"description":21,"interventionNames":22},"Esketamine dose 3","During anesthesia, a loading dose esketamine (1.5 mg\u002Fml) 0.4 ml\u002Fkg will be infused over 30 minutes (0.3 mg\u002Fkg) after anesthesia induction, followed by a continuous infusion at 0.1 ml\u002Fkg\u002Fh (0.15 mg\u002Fkg\u002Fh) until 1 hour before the expected end of surgery.\n\nAfter surgery, patient-controlled intravenous analgesia will be established with esketamine (0.75 mg\u002Fml) and sufentanil (1 ug\u002Fml), programmed to deliver 2-ml bolus (1.5 mg esketamine) with a 8-10-minute lock-out time and a 1-ml\u002Fh (0.75 mg\u002Fh esketamine) background infusion, and used for up to 48 hours.",[23],"Drug: Esketamine 3",{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo","PLACEBO_COMPARATOR","During anesthesia, a loading dose placebo (normal saline) 0.4 ml\u002Fkg will be infused over 30 minutes after anesthesia induction, followed by a continuous infusion at 0.1 ml\u002Fkg\u002Fh until 1 hour before the expected end of surgery.\n\nAfter surgery, patient-controlled intravenous analgesia will be established with sufentanil (1 ug\u002Fml), programmed to deliver 2-ml bolus with a 8-10-minute lock-out time and a 1-ml\u002Fh background infusion, and used for up to 48 hours.",[29],"Drug: Normal saline",[31,36,41,45],{"type":32,"name":33,"description":11,"armGroupLabels":34,"otherNames":35},"DRUG","Esketamine 1",[9],[9],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Esketamine 2","During anesthesia, a loading dose esketamine (1.0 mg\u002Fml) 0.4 ml\u002Fkg will be infused over 30 minutes (0.2 mg\u002Fkg) after anesthesia induction, followed by a continuous infusion at 0.1 ml\u002Fkg\u002Fh (0.1 mg\u002Fkg\u002Fh) until 1 hour before the expected end of surgery.\n\nAfter surgery, patient-controlled intravenous analgesia will be established with esketamine (0.5 mg\u002Fml) and sufentanil (1 ug\u002Fml), programmed to deliver 2-ml bolus (1 mg esketamine) with a 8-10-minute lock-out time and a 1-ml\u002Fh (0.5 mg\u002Fh esketamine) background infusion, and used for up to 48 hours.",[15],[15],{"type":32,"name":42,"description":21,"armGroupLabels":43,"otherNames":44},"Esketamine 3",[20],[20],{"type":32,"name":46,"description":27,"armGroupLabels":47,"otherNames":48},"Normal saline",[25],[25],[50],{"name":51,"affiliation":5,"role":52},"Dong-Xin Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[54,59],{"name":51,"role":55,"phone":56,"phoneExt":57,"email":58},"CONTACT","+86 13910731903",null,"wangdongxin@hotmail.com",{"name":60,"role":55,"phone":57,"phoneExt":57,"email":61},"Jia-Hui Ma, PhD","mjh@bjmu.edu.cn",[63,77],{"facility":5,"status":57,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Beijing","Beijing Municipality","100034","China","CN",{"type":70,"coordinates":71},"Point",[72,73],116.39723,39.9075,{"lat":73,"lon":72},[76],{"name":60,"role":55,"phone":57,"phoneExt":57,"email":61},{"facility":78,"status":57,"city":79,"state":80,"zip":81,"country":67,"countryCode":68,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Tianjin Medical University General Hospital","Tanjing","Tianjing","300052",{"type":70,"coordinates":83},[84,85],121.45319,31.9467,{"lat":85,"lon":84},[88],{"name":89,"role":55,"phone":57,"phoneExt":57,"email":90},"Yi-Ze Li, MD","liyizelisa@126.com",{"type":52,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"Dong-Xin Wang","Professor and Chairman, Department of Anaesthesiology",[95],{"name":78,"class":6},"100633180","phase-4-impact-of-esketamine-on-delayed-neurocognitive-recovery-in-older-patients-100633180",false,"NCT07523334","Impact of Esketamine on Delayed Neurocognitive Recovery in Older Patients","Impact of Esketamine on Delayed Neurocognitive Recovery in Older Patients Undergoing Non-cardiac Surgery: a Two-center, Dose-exploring Pilot Trial","Inclusion Criteria:\n\n1. Aged \\>=65 but \\\u003C= 90 years;\n2. Scheduled to undergo non-cardiac surgery with an expected duration of \\>= 2 hours under general anesthesia;\n3. Requiring patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n1. Unable to communicate preoperatively due to visual or auditory impairment, language barrier, or severe dementia;\n2. Comorbid with schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;\n3. Traumatic brain injury or neurosurgery;\n4. Severe hepatic dysfunction (Child-Pugh Class C), severe renal dysfunction (receiving dialysis preoperatively), or American Society of Anesthesiologists physical status classification \\>= Ⅳ;\n5. Expected admission to the Intensive Care Unit with endotracheal intubation after surgery;\n6. Anaphylaxis to esketamine;\n7. Participation in other clinical studies, or any other conditions that are considered unsuitable to be involved in the study.",true,"ALL","65 Years","90 Years",{"count":108,"type":109},120,"ESTIMATED","INTERVENTIONAL",[112],"PHASE4","Esketamine is frequently used during the perioperative period for supplemental analgesia. Small sample size trials showed that subanesthetic dose esketamine may decrease postoperative neurocognitive complications. However, conflicting results exist and optimal dose of esketamine remains to be determined. This dose-exploring pilot trial is designed to evaluate the safety and efficacy of three different perioperative esketamine dosing regimens in older patients undergoing major non-cardiac surgery. The primary purpose is to explore the optimal dosing strategy that produce maximal neurocognitive benefits with minimal adverse neuropsychiatric symptoms.",[115,116,117,118,119],"Elderly","Noncardiac Surgery","Delayed Neurocognitive Recovery","Postoperative Delirium","Esketamine",[121,122,123,124,119],"Older patients","Noncardiac surgery","Delayed neurocognitive recovery","Postoperative delirium","NOT_YET_RECRUITING","2026-04-09",{"date":128,"type":129},"2026-04-14","ACTUAL",{"date":131,"type":109},"2026-04",{"date":133,"type":109},"2026-12",{"name":5,"class":6},2]