[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633179":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":61,"collaborators":41,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":41,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":41,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":90,"whyStopped":41,"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 sufentanil 1.25 ug\u002Fh) 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 (sufentanil 1.25 ug\u002Fh) 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","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Dong-Xin Wang, MD, PhD","CONTACT","01083572784",null,"wangdongxin@hotmail.com",{"name":44,"role":39,"phone":41,"phoneExt":41,"email":45},"Huai-Jin Li, MD","sophie.lee.coffee@gmail.com",[47],{"facility":5,"status":41,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Beijing","Beijing Municipality","100034","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60],{"name":44,"role":39,"phone":40,"phoneExt":41,"email":45},{"type":35,"investigatorFullName":34,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Chief Physician, Professor","100633179","phase-4-dexmedetomidine-esketamine-combination-and-moderate-to-severe-pain-after-spinal-surgery-100633179",false,"NCT07523321","Dexmedetomidine-esketamine Combination and Moderate-to-severe Pain After Spinal Surgery","Effect of Perioperative Use of Dexmedetomidine-esketamine Combination on Incidence of Moderate-to-severe Pain After Spinal Surgery: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged \\>= 40 years but \\\u003C 80 years;\n2. Scheduled to undergo elective posterior cervical, thoracic, or lumbar spine surgery with an expected duration \\>= 2 hours under general anesthesia;\n3. Required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n1. Uncontrolled preoperative hypertension (ward systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg);\n2. Severe bradycardia (heart rate \\\u003C= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, a history of myocardial infarction within one year, or presence of rapid ventricular arrhythmia;\n3. History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, or prresence of intracranial hypertension;\n4. Uncontrolled hyperthyroidism or pheochromocytoma;\n5. Inability to communicate due to coma, severe dementia, or language barrier;\n6. Severe cardiac insufficiency (preoperative left ventricular ejection fraction \\\u003C 30% or New York Heart Association Functional classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (preoperative dialysis), or American Society of Anesthesiologists physical status \\>= IV;\n7. Other conditions that are considered unsuitable for study participation.","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 improve analgesia and reduce moderate-to-severe pain 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","2026-04-09",{"date":93,"type":94},"2026-04-14","ACTUAL",{"date":96,"type":75},"2026-04",{"date":98,"type":75},"2027-05",{"name":5,"class":6},1]