[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552080":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":92,"collaborators":95,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":39,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":39,"enrollmentInfo":107,"targetDuration":39,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":120,"overallStatus":121,"whyStopped":39,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine-Esketamine Combination","EXPERIMENTAL","Sedation-analgesia is provided with dexmedetomidine-esketamine combination for up to 14 days or until discharge from the ICU. The formulation consists of dexmedetomidine 200 μg\u002F2 ml and esketamine 100 mg\u002F4 ml, diluted with normal saline to a total volume of 50 ml, resulting in a dexmedetomidine concentration of 4 μg\u002Fml and an esketamine concentration of 2 mg\u002Fml.",[13],"Drug: Dexmedetomidine-Esketamine Combination",{"label":15,"type":16,"description":17,"interventionNames":18},"Dexmedetomidine","ACTIVE_COMPARATOR","Sedation-analgesia is provided with dexmedetomidine for up to 14 days or until discharge from the ICU. The formulation consists of dexmedetomidine 200 μg\u002F2 ml, diluted with normal saline to a total volume of 50 ml, resulting in a dexmedetomidine concentration of 4 μg\u002Fml.",[19],"Drug: Dexmedetomidine",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","For patients with invasive ventilation, nighttime sedation (20:00-06:00) is provided with an initial infusion rate of \\[0.05×kg\\] ml\u002Fh which is increased by \\[0.025×kg\\] ml\u002Fh every 10 min, until the Richmond Agitation-Sedation Scale (RASS) reaches -2 to -1, maximal infusion rate reaches \\[0.175×kg\\] ml\u002Fh, or adverse reactions occur. Daytime sedation (06:00-20:00) is provided as above when considered necessary by the ICU physicians, with a target RASS score of -2 to +1.\n\nFor patients with non-invasive ventilation (including high-flow nasal oxygenation) or without assisted ventilation, nighttime sedation (20:00-06:00) is provided with an initial infusion rate of \\[0.0125×kg\\] ml\u002Fh which is increased by \\[0.0125×kg\\] ml\u002Fh every 10 min, until the RASS reaches -1, maximal infusion rate reaches \\[0.05×kg\\] ml\u002Fh, or adverse reactions occur. Daytime sedation (06:00-20:00) is typically not required but is provided when considered necessary by the ICU physicians, with a target RASS score of -1 to +1.",[9],[26,27],"Dexmedetomidine hydrochloride","Esketamine hydrochloride",{"type":22,"name":15,"description":23,"armGroupLabels":29,"otherNames":30},[15],[26],[32],{"name":33,"affiliation":5,"role":34},"Dong-Xin Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","8610 83572784",null,"wangdongxin@hotmail.com",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Xian Su, MD, PhD","8610 83575138","suxxxx@126.com",[46,62,77],{"facility":5,"status":39,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Beijing","Beijing Municipality","100034","China","CN",{"type":53,"coordinates":54},"Point",[55,56],116.39723,39.9075,{"lat":56,"lon":55},[59,60,61],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},{"name":33,"role":34,"phone":39,"phoneExt":39,"email":39},{"facility":63,"status":39,"city":47,"state":48,"zip":64,"country":50,"countryCode":51,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Peking University International Hospital","102206",{"type":53,"coordinates":66},[55,56],{"lat":56,"lon":55},[69,73],{"name":70,"role":37,"phone":71,"phoneExt":39,"email":72},"Gang Li, MD","+86 13521809822","ligang@pkuih.edu.cn",{"name":74,"role":37,"phone":75,"phoneExt":39,"email":76},"Hong-Xun Yuan, MD","+86 13601199951","yuanhongxun@pkuih.edu.cn",{"facility":78,"status":39,"city":79,"state":80,"zip":81,"country":50,"countryCode":51,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Tianjin Medical University General Hospital","Tianjin","Tianjin Municipality","300052",{"type":53,"coordinates":83},[84,85],117.17667,39.14222,{"lat":85,"lon":84},[88],{"name":89,"role":37,"phone":90,"phoneExt":39,"email":91},"Ke-Liang Xie, MD","+86 15332112099","xiekeliang2009@hotmail.com",{"type":34,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Dong-Xin Wang","Professor and Chairman, Department of Anesthesiology",[96,97],{"name":63,"class":6},{"name":78,"class":6},"100552080","dexmedetomidine-esketamine-combination-for-sedation-and-analgesia-in-icu-patients-100552080",false,"NCT06468436","Dexmedetomidine-Esketamine Combination for Sedation and Analgesia in ICU Patients","Effect of Dexmedetomidine-Esketamine Combination for Sedation and Analgesia on Delirium in ICU Patients With Mechanical Ventilation: A Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Aged ≥18 years;\n2. Receiving invasive or non-invasive mechanical ventilation in the ICU, with an expected duration ≥24 hours;\n3. Require sedation as judged by ICU physicians.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;\n3. Unable to communicate due to coma, severe dementia, or language barrier prior to invasive\u002Fnon-invasive mechanical ventilation;\n4. After stroke, hypoxic encephalopathy, traumatic brain injury, or neurosurgery;\n5. Comorbid with hyperthyroidism or pheochromocytoma;\n6. Left ventricular ejection fraction \\\u003C30%, sick sinus syndrome, severe sinus bradycardia (heart rate \\\u003C50 bpm), second-degree or higher atrioventricular block without a pacemaker, or systolic blood pressure \\\u003C90 mmHg despite use of vasopressors;\n7. Severe liver dysfunction (Child-Pugh Class C), severe renal dysfunction (requiring dialysis), or expected survival ≤24 hours;\n8. Allergy to dexmedetomidine and\u002For esketamine, or any other conditions that are considered unsuitable for study participation.","ALL","18 Years",{"count":108,"type":109},1508,"ESTIMATED","INTERVENTIONAL",[112],"NA","Patients with mechanical ventilation in the intensive care unit (ICU) often develop anxiety and agitation, sleep distuebances, and delirium. Delirium occurrence is associated with worse early and long-term outcomes. Dexmedetomidine and ketamine are recommended for sedation and analgesia in ICU patients, but each may induce side effects. The sedative effects of dexmedetomidine can help mitigate the psychiatric side effects of esketamine. Recent studies showed that dexmedetomidine-esketamine combination improved analgesia and sleep quality without increasing psychiatric side effects. This trial is designed to test the hypothesis that dexmedetomidine-esketamine combination for sedation and analgesia in ICU patients with mechanical ventilation may reduce delirium and improve respiratory recovery.",[115,116,117,15,118,119],"Aged","Intensive Care Units","Ventilators, Mechanical","Esketamine","Delirium",[115,116,117,15,118,119],"NOT_YET_RECRUITING","2025-07-28",{"date":124,"type":125},"2025-07-31","ACTUAL",{"date":127,"type":109},"2025-11",{"date":129,"type":109},"2030-12-01",{"name":5,"class":6},3]