[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522814":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":62,"collaborators":29,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":29,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":29,"enrollmentInfo":74,"targetDuration":29,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":86,"overallStatus":46,"whyStopped":29,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-dose group","ACTIVE_COMPARATOR","Patient-controlled analgesia is established with esketamine 50 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram\u002Fkg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lockout interval of 8 minutes and a background infusion rate at 1 ml\u002Fh.",[13],"Drug: Esketamine",{"label":15,"type":16,"description":17,"interventionNames":18},"medium-dose group","EXPERIMENTAL","Patient-controlled analgesia is established with esketamine 100 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram\u002Fkg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lockout interval of 8 minutes and a background infusion rate at 1 ml\u002Fh.",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"High-dose group","Patient-controlled analgesia is established with esketamine 150 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram\u002Fkg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lockout interval of 8 minutes and a background infusion rate at 1 ml\u002Fh.",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Esketamine","Different doses of esketamine in the esketamine-dexmedetomidine combination as a supplement to sufentanil for postoperative analgesia.",[20,9,15],null,[31],{"name":32,"affiliation":5,"role":33},"Dong-Xin Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":29,"email":38},"CONTACT","8610-83572784","wangdongxin@hotmail.com",{"name":40,"role":36,"phone":41,"phoneExt":29,"email":42},"Fan Cui, MD","8610-83572460","cuifan_1987@163.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Beijing University First Hospital","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":60,"role":36,"phone":37,"phoneExt":29,"email":38},"Dong-Xin Wang, MD, PHD",{"name":40,"role":36,"phone":41,"phoneExt":29,"email":42},{"type":33,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Dong-Xin Wang","Professor and Chairman, Department of Anesthesiology","100522814","phase-4-different-dose-esketamine-and-dexmedetomidine-for-supplemental-analgesia-and-longterm-outcomes-100522814",false,"NCT06087510","Different Dose Esketamine and Dexmedetomidine for Supplemental Analgesia and Longterm Outcomes","Impact of Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia on Long-term Outcomes After Scoliosis Correction Surgery: Follow-up of a Randomized Trial","Inclusion Criteria:\n\n* Patients aged ≥18 years and body weight≥40 kg;\n* Scheduled to undergo scoliosis correction with pedicle screw fixation;\n* Required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n* Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate \\\u003C50 beats per minute), atrioventricular block grade II or above without pacemaker, congenital heart disease, arrhythmia, or other serious cardiovascular diseases with a New York Heart Association class ≥III;\n* Patients with moderate or severe obstructive sleep apnea diagnosed preoperatively or according to the STOP-Bang score;\n* History of hyperthyroidism or pheochromocytoma;\n* History of schizophrenia, epilepsy, myasthenia gravis;\n* Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anaesthesiologists grade ≥IV;\n* Barrier in communication;\n* Other conditions that were considered unsuitable for study participation.","ALL","18 Years",{"count":75,"type":76},312,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","Chronic postsurgical pain (CPSP) refers to pain that occurs or increases after surgery and lasts longer than 3 months. Severe acute postoperative pain is one of the major risk factors of CPSP. Spinal correction surgery is associated with severe pain due to large trauma and long duration. Ketamine and esketamine are N-methyl-D-aspartate receptor antagonists; they have antihyperalgesic effects and may reduce CPSP. Dexmedetomidine is an alpha 2-adrenoceptor agonist with sedative, anxiolytic, and analgesic effect; it is frequently used as an adjuvant to postoperative analgesia. In a previous trial of 200 patients after scoliosis correction surgery, mini-dose esketamine-dexmedetomidine in combination with opioids significantly improved analgesia and sleep quality but did not reduce CPSP. The authors speculate that increasing esketamine dose in the combination may further improve analgesia and, therefore, reduce the occurrence of CPSP.",[82,83,26,84,85],"Scoliosis Correction","Postoperative Analgesia","Dexmedetomidine","Chronic Postsurgical Pain",[82,87,26,84,85],"Postoperative analgesia","2025-07-29",{"date":90,"type":91},"2025-07-30","ACTUAL",{"date":93,"type":91},"2024-01-24",{"date":95,"type":76},"2026-09",{"name":5,"class":6},1]