[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559619":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":39,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":39,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":39,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":46,"whyStopped":39,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine-esketamine combination","EXPERIMENTAL","Patient-controlled analgesia is established with dexmedetomidine (1 μg\u002Fml), esketamine (1 mg\u002Fml), and sufentanil (1 μg\u002Fml) in a total volume of 100 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml\u002Fh. Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours after surgery.",[13],"Drug: Dexmedetomidine-esketamine combination",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patient-controlled analgesia is established with sufentanil (1 μg\u002Fml) in a total volume of 100 ml. The pump is programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate at 1 ml\u002Fh. Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours after surgery.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],[25],"Dexmedetomidine-esketamine group",{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":28},[15],[29],"Placebo group",[31],{"name":32,"affiliation":5,"role":33},"Dong-Xin Wang, M.D.","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Xin-Quan Liang, M.D.","CONTACT","+86 152 1084 6532",null,"liangxinquan09@163.com",{"name":32,"role":37,"phone":42,"phoneExt":39,"email":43},"8610 83572784","wangdongxin@hotmail.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":53,"coordinates":54},"Point",[55,56],116.39723,39.9075,{"lat":56,"lon":55},[59,61],{"name":36,"role":37,"phone":60,"phoneExt":39,"email":40},"8615210846532",{"name":32,"role":37,"phone":42,"phoneExt":39,"email":43},{"type":33,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Dong-Xin Wang","Professor and Chairman, Department of Anesthesiology","100559619","phase-4-mini-dose-dexmedetomidine-esketamine-supplemented-analgesia-in-patients-at-high-risk-of-osa-100559619",false,"NCT06566482","Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA","Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia for Postoperative Sleep Promotion in Patients at High-risk of Obstructive Sleep Apnea: A Randomized Trial","Inclusion criteria:\n\n1. Aged ≥18 years but ≤80 years;\n2. Preoperative diagnosis of OSA, or judged to be at moderate-to-high risk of OSA according to the STOP-Bang Questionnaire;\n3. Scheduled to undergo thoracoscopic or laparoscopic surgery under general anesthesia, with an expected surgical duration of ≥1 hours, and required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion criteria:\n\n1. Diagnosed as central sleep apnea syndrome;\n2. Previous history of schizophrenia, epilepsy, Parkinson disease, or myasthenia gravis.\n3. History of schizophrenia, or having antipsychotic drugs (including antidepressants or anxiolytics);\n4. Inability to communicate in the preoperative period because of coma, profound dementia, or deafness;\n5. History of drug or alcohol dependence, or sedative or hypnotic therapy within 1 month before surgery;\n6. Contraindications to ketamine (such as hyperthyroidism, pheochromocytoma, or glaucoma);\n7. Sick sinus syndrome, severe sinus bradycardia (\\\u003C50 beats per minute), or second-degree or above atrioventricular block without pacemaker;\n8. Contraindications to high-flow nasal cannula therapy (such as mediastinal emphysema, shock or hypotension, cerebrospinal fluid leakage, nasosinusitis, otitis media, or deviation of nasal septum);\n9. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy), severe heart dysfunction (preoperative New York Heart Association functional classification ≥3 or left ventricular ejection fraction \\\u003C30%), or ASA classification IV or above;\n10. Expected intensive care unit (ICU) admission with tracheal intubation after surgery;\n11. Other conditions that are considered unsuitable for study participation.","ALL","18 Years","80 Years",{"count":76,"type":77},100,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","Patients with obstructive sleep apnea (OSA) are at increased risk of developing sleep disturbances after surgery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, analgesic, and anxiolytic effects. Ketamine is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine and twice as potent as racemic ketamine for analgesia. A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery. This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve postoperative sleep quality in patients at high-risk of OSA.",[83,84,85,86,87],"Obstructive Sleep Apnea","Surgery","Dexmedetomidine","Esketamine","Postoperative Sleep Quality",[83,84,85,86,89],"Postoperative sleep quality","2024-09-23",{"date":92,"type":93},"2024-09-25","ACTUAL",{"date":95,"type":93},"2024-09-11",{"date":97,"type":77},"2025-12",{"name":5,"class":6},1]