[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652085":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":54,"locations":60,"responsibleParty":79,"collaborators":36,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":36,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":36,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":36,"overallStatus":63,"whyStopped":36,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Affiliated Hospital of Nantong University","OTHER",[8,16,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"FNB + Placebo","EXPERIMENTAL","Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg\u002F(kg·h) as placebo.",[13,14,15],"Drug: ropivacaine (local infiltration)","Drug: Normal saline placebo","Procedure: Femoral Nerve Block",{"label":17,"type":10,"description":18,"interventionNames":19},"FNB + Dexmedetomidine","Femoral nerve block (FNB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg\u002F(kg·h).",[13,20,15],"Drug: Dexmedetomidine",{"label":22,"type":10,"description":23,"interventionNames":24},"ACB + Placebo","Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of normal saline at 0.5 μg\u002F(kg·h) as placebo.",[13,14,25],"Procedure: Adductor canal block",{"label":27,"type":10,"description":28,"interventionNames":29},"ACB + Dexmedetomidine","Adductor canal block (ACB) with 20mL of 0.375% ropivacaine, combined with intraoperative continuous infusion of dexmedetomidine at 0.5 μg\u002F(kg·h).",[13,20,25],[31,37,41,45,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","ropivacaine (local infiltration)","0.375% ropivacaine solution, 20 mL, administered as a single-shot peripheral nerve block prior to anesthesia induction.",[27,22,17,9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Dexmedetomidine","0.5 μg\u002F(kg·h) continuous intravenous infusion, initiated after anesthesia induction and discontinued 30 minutes before the end of surgery.",[27,17],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Normal saline placebo","0.9% normal saline solution, administered as a continuous intravenous infusion at a volume rate matching the dexmedetomidine group (0.5 μg\u002Fkg\u002Fh equivalent), started after induction and stopped 30 minutes before surgery end.",[22,9],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"PROCEDURE","Femoral Nerve Block","Ultrasound-guided femoral nerve block performed at the inguinal region (approximately 2 cm distal to the inguinal ligament) using an in-plane technique. A total of 20 mL of 0.375% ropivacaine is injected 1-2 mm anterior to the femoral nerve.",[17,9],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":36},"Adductor canal block","Ultrasound-guided adductor canal block performed via the distal approach at the mid-to-lower third of the medial thigh, targeting the adductor hiatus. A total of 20 mL of 0.375% ropivacaine is injected.",[27,22],[55],{"name":56,"role":57,"phone":58,"phoneExt":36,"email":59},"Ma XQ Ma Xia Qing, doctorate","CONTACT","0086-18118660387","lvy_Ma@ntu.edu.cn",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"The Affiliated Hospital of Nantong University","RECRUITING","Nantong","Jiangsu","211600","China","CN",{"type":70,"coordinates":71},"Point",[72,73],120.87472,32.03028,{"lat":73,"lon":72},[76],{"name":77,"role":57,"phone":78,"phoneExt":36,"email":59},"Ma XQ Ma Xia Qing, PhD","18118660387",{"type":80,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100652085","phase-4-effect-of-dexmedetomidine-combined-with-fnbacb-on-sleep-quality-after-knee-surgery-100652085",false,"NCT07767383","Effect of Dexmedetomidine Combined With FNB\u002FACB on Sleep Quality After Knee Surgery","Effect of Dexmedetomidine Combined With FNB\u002FACB on Sleep Quality After Knee Surgery: A Randomized Controlled Factorial Trial","Inclusion Criteria:\n\n1. Age 18 to 85 years.\n2. American Society of Anesthesiologists (ASA) physical status I to III.\n3. Body Mass Index (BMI) between 18 and 30 kg\u002Fm² and body weight \\> 50 kg.\n4. Scheduled for elective knee arthroscopy under general anesthesia.\n5. Complete preoperative workup, confirmed diagnosis, and indication for knee arthroscopy with complete postoperative medical records.\n6. Normal mental and cognitive status.\n7. Patient or legally authorized representative has provided written informed consent for anesthesia and study participation.\n\nExclusion Criteria:\n\n1. Refusal to participate in the study.\n2. Inability to communicate effectively.\n3. Known allergy or contraindication to any study drug (ropivacaine, dexmedetomidine, propofol, sufentanil, remifentanil, vecuronium, or sevoflurane).\n4. History of knee trauma or knee surgery; diagnosed with immune system disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus); neuromuscular diseases or psychiatric disorders; restless legs syndrome (RLS); periodic limb movement disorder (PLMD).\n5. Coagulation disorders or local infection at the puncture site precluding peripheral nerve block.\n6. Severe hepatic or renal dysfunction.\n7. Severe cardiopulmonary insufficiency.\n8. Pregnancy.\n9. Diagnosis of obstructive sleep apnea (OSA) or requirement for continuous positive airway pressure (CPAP) therapy.\n10. Regular use of sedative-hypnotic drugs (benzodiazepines, non-benzodiazepine hypnotics, melatonin receptor agonists, etc.) or antidepressants\u002Fanxiolytics known to affect sleep architecture (e.g., trazodone, mirtazapine) within the past 1 month.\n11. Pittsburgh Sleep Quality Index (PSQI) score \\> 5.",true,"ALL","18 Years","85 Years",{"count":93,"type":94},136,"ESTIMATED","INTERVENTIONAL",[97],"PHASE4","The goal of this randomized, double-blind, placebo-controlled, 2×2 factorial trial is to evaluate the effect of intraoperative dexmedetomidine combined with either femoral nerve block (FNB) or adductor canal block (ACB) on postoperative sleep quality in patients aged 18-85 years with ASA I-III undergoing elective knee arthroscopy under general anesthesia.\n\nThe main questions it aims to answer are:\n\n1. Does intraoperative dexmedetomidine infusion (0.5 μg\u002Fkg\u002Fh) improve postoperative sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) at 24 h and 48 h after surgery?\n2. Is there an interaction between the type of nerve block (FNB vs. ACB) and the use of dexmedetomidine on postoperative sleep quality?",[100],"Knee Arthroscopic Surgery","2026-08-13",{"date":103,"type":104},"2026-08-17","ACTUAL",{"date":106,"type":104},"2026-01-15",{"date":108,"type":94},"2026-12-31",{"name":5,"class":6},1]