[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582175":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":83,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine-esketamine group","EXPERIMENTAL","Dexmedetomidine-esketamine combination is infused during general anesthesia and used as a supplement for patient-controlled intravenous analgesia after surgery.",[13],"Drug: Dexmedetomidine-esketamine combination",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Placebo (normal saline) is infused during general anesthesia and used as a supplement for patient-controlled intravenous analgesia after surgery.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine-esketamine combination","Dexmedetomidine 0.4 μg\u002Fkg and esketamine 0.2 mg\u002Fkg is infused over 10 minutes before anesthesia induction. Dexmedetomidine 0.20 μg\u002Fkg\u002Fh and esketamine 0.10 mg\u002Fkg\u002Fh is then infused until 60 minutes before the expected end of surgery. Patient-controlled intravenous analgesia is established with 100 μg dexmedetomidine, 50 mg esketamine, and 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL\u002Fh for up to 72 hours after surgery.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo (normal saline) is administered in the same rate and volume as that in the dexmedetomidine-esketamine group. Patient-controlled intravenous analgesia is established with 100 μg sufentanil, diluted to 100 mL with normal saline, and programmed to deliver 2-mL boluses with a lock-out interval of 8 minutes and background infusion rate at 1 mL\u002Fh for up to 72 hours after surgery.",[15],[32],{"name":33,"affiliation":34,"role":35},"Dong-Xin Wang","Dong-Xin Wang, MD, PhD, Peking University First Hospital","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Mo Li, MD, PhD","CONTACT","+86 19801260665","2361011139@pku.edu.cn",[43],{"facility":5,"status":44,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Beijing","100034","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":38,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mo Li","Anesthesiologist, Department of Anesthesiology","100582175","phase-4-dexmedetomidine-esketamine-combination-and-sleep-disturbances-after-major-noncardiac-surgery-100582175",false,"NCT06859892","Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery","Effect of Dexmedetomidine-esketamine Combination on Sleep Disturbances After Major Noncardiac Surgery: a Single-center, Randomised, Double-blind, Placebo-controlled Trial","Inclusion Criteria:\n\n1. Aged ≥18 years.\n2. Scheduled for major noncardiac surgery (≥60 minutes) under general anesthesia with an expected end of surgery no later than 18:00 pm.\n3. Required patient-controlled intravenous analgesia after surgery.\n\nExclusion Criteria:\n\n1. Emergency surgery, transurethral surgery, organ transplantation.\n2. Pregnant or lactating women.\n3. Patients who need hypnotics for sleep disturbance or antidepressants for depression prior to surgery.\n4. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.\n5. Inability to communicate due to coma, severe dementia, or speech disorders, endured hypoxic encephalopathy or traumatic brain injury, or after neurosurgery.\n6. Comorbid with hyperthyroidism and pheochromocytoma.\n7. Preoperative left ventricular ejection fraction \\\u003C30%, sick sinus syndrome, severe sinus bradycardia (heart rate \\\u003C50 beats\u002Fmin), atrioventricular block of degree II or higher without pacemaker implantation, or systolic blood pressure below 90 mmHg despite use of vasopressors.\n8. Diagnosed as sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea as assessed by STOP-Bang.\n9. Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (on dialysis), or ASA classification ≥IV.\n10. Hypersensitive to dexmedetomidine and\u002For esketamine.\n11. Other conditions that are deemed unsuitable for study participation.","ALL","18 Years",{"count":71,"type":72},476,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery. The purpose of this trial is to test the hypothesis that dexmedetomidine-esketamine combination used as a supplement during general anesthesia and postoperative intravenous analgesia may reduce sleep disturbances in adult after major noncardiac surgery.",[78,79,80,81,82],"Adults","Major Noncardiac Surgery","Dexmedetomidine","Esketamine","Postoperative Sleep Disturbances",[84,85,86,87,88],"adults","major noncardiac surgery","dexmedetomidine","esketamine","postoperative sleep disturbances","2025-03-18",{"date":91,"type":92},"2025-03-19","ACTUAL",{"date":89,"type":92},{"date":95,"type":72},"2026-12",{"name":5,"class":6},1]