[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633385":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":60,"collaborators":40,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":40,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":40,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":90,"whyStopped":40,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined dexmedetomidine-esketamine group","EXPERIMENTAL","During anesthesia, a loading dose (0.2 ml\u002Fkg) of dexmedetomidine-esketamine (DEX-ESK) combination (DEX 2 ug\u002Fml; ESK 1 mg\u002Fml) will be infused after anesthesia induction (DEX 0.4 ug\u002Fkg; ESK 0.2 mg\u002Fkg), followed by a continuous infusion at 0.1 ml\u002Fkg\u002Fh (DEX 0.2 ug\u002Fkg\u002Fh; ESK 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 dexmedetomidine (DEX 1.5 ug\u002Fml), esketamine (ESK 0.5 mg\u002Fml), and sufentanil (1.25 ug\u002Fml), programmed to deliver 2-ml boluses (DEX 3.0 ug, ESK 1 mg, and sufentanil 2.5 ug) with a 8-10-minute lockout interval and a 1-ml\u002Fh (DEX 1.5 ug\u002Fh, ESK 0.5 mg\u002Fh, and 1.25 ug\u002Fh sufentanil) background infusion, and used for up to 48 hours.",[13],"Drug: Combined dexmedetomidine-esketamine administration",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","During anesthesia, a loading dose (0.2 ml\u002Fkg) of normal saline will be infused 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 (1.25 ug\u002Fml), programmed to deliver 2-ml boluses (sufentanil 2.5 ug) with a 8-10-minute lockout interval and a 1-ml\u002Fh (1.25 ug\u002Fh sufentanil) background infusion, and used for up to 48 hours.",[19],"Drug: Placebo administration",[21,27],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Combined dexmedetomidine-esketamine administration",[9],[26],"Dexmedetomidine and esketamine",{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":30},"Placebo administration",[15],[31],"Placebo (normal saline)",[33],{"name":34,"affiliation":5,"role":35},"Dong-Xin Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","01083572784",null,"wangdongxin@hotmail.com",{"name":43,"role":38,"phone":40,"phoneExt":40,"email":44},"Huai-Jin Li, MD","sophie.lee.coffee@gmail.com",[46],{"facility":5,"status":40,"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],{"name":43,"role":38,"phone":40,"phoneExt":40,"email":44},{"type":35,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Dong-Xin Wang","Chief Physician, Professor","100633385","phase-4-dexmedetomidine-esketamine-combination-and-chronic-postsurgical-pain-after-spinal-surgery-100633385",false,"NCT07525999","Dexmedetomidine-esketamine Combination and Chronic Postsurgical Pain After Spinal Surgery","Effect of Perioperative Use of Dexmedetomidine-esketamine Combination on Incidence of Chronic Postsurgical Pain After Spinal Surgery: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged \\>= 40 years and \\\u003C 80 years;\n2. Scheduled to undergo elective posterior cervical, thoracic or lumbar spine surgery under general anesthesia, with an expected operative duration \\>= 2 hours;\n3. Requirement for patient-controlled intravenous analgesia (PCIA) postoperatively.\n\nExclusion Criteria:\n\n1. Severe uncontrolled hypertension preoperatively (baseline ward blood pressure: SBP \\> 180 mmHg or DBP \\> 110 mmHg);\n2. Severe bradycardia (heart rate \\\u003C= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, or a history of myocardial infarction within one year, severe heart failure (NYHA class \\>= III), or rapid ventricular arrhythmia;\n3. Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension;\n4. Preoperative history of hyperthyroidism or pheochromocytoma;\n5. Inability to communicate preoperatively due to coma, severe dementia, or language impairment;\n6. Severe cardiac insufficiency (preoperative LVEF \\\u003C 30% or NYHA class IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (preoperative dialysis), or ASA physical status \\>= grade IV;\n7. Other conditions deemed inappropriate for study participation by the investigator or attending physician.","ALL","40 Years","80 Years",{"count":74,"type":75},274,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","Spinal surgery is generally followed by severe postoperative pain, and poor pain control may cause adverse outcomes such as cardiovascular events, neurocognitive disorders, and chronic postsurgical pain (CPSP). In previous studies, perioperative use of dexmedetomidine or esketamine is each associated with improved analgesia after surgery. Recent studies suggest that combined use of dexmedetomidine and esketamine may produce synergetic effects in improving analgesia. This trial is designed to test the hypothesis that perioperative combined use of dexmedetomidine and esketamine may reduce CPSP in patients after spinal surgery.",[81,82,83,84,85],"Spinal Surgery","Pain Intensity","Dexmedetomidine","Esketamine","Postoperative Analgesia",[87,88,83,84,89],"Spinal surgery","Pain intensity","Postoperative analgesia","NOT_YET_RECRUITING","2026-04-13",{"date":93,"type":94},"2026-04-16","ACTUAL",{"date":96,"type":75},"2026-04",{"date":98,"type":75},"2027-12",{"name":5,"class":6},1]