[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559467":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":59,"studyPopulation":47,"armGroups":60,"interventions":74,"overallOfficials":87,"centralContacts":92,"locations":97,"responsibleParty":112,"collaborators":47,"id":115,"slug":47,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":47,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":47,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":138,"whyStopped":47,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Fujian Provincial Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"The incidence of postoperative delirium within the first three postoperative days","The incidence of POD within the first three postoperative days will be assessed using the Confusion Assessment Method (CAM). The CAM evaluates four diagnostic features: (1) acute onset or fluctuating course, (2) inattention, (3) disorganised thinking and (4) altered consciousness. Delirium is diagnosed when features 1 and 2 are present, with either 3 or 4. Blinded investigators will assess for POD at least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days.","At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days",[14,17,20,24,28,32,36,40,43],{"measure":15,"description":16,"timeFrame":12},"Delirium severity","Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity",{"measure":18,"description":19,"timeFrame":12},"Delirium subtypes","Richmond Agitation Sedation Scale (RASS); hypoactive (-3 to 0), hyperactive (+1 to +4) or mixed",{"measure":21,"description":22,"timeFrame":23},"Cognitive function","Abbreviated Mental Test Score (AMTS) via telephone at 1, 3, 6 and 12 months postoperatively","At 1, 3, 6 and 12 months postoperatively",{"measure":25,"description":26,"timeFrame":27},"Anxiety and depression","Hospital Anxiety and Depression Scale (HADS); 14-item checklist (7 for anxiety, 7 for depression); each item scored 0-3; total score \\>8 suggests mild disorder, \\>10 moderate disorder","Assessed preoperatively and daily for three days postoperatively",{"measure":29,"description":30,"timeFrame":31},"Postoperative pain","11-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at rest and movement","Assessed at 1, 3, 6, 12, 24, 36, 48, 60 and 72 hours postsurgery",{"measure":33,"description":34,"timeFrame":35},"Postoperative morphine consumption","Cumulative morphine use and rescue analgesia recorded over 72 hours postsurgery","During 72 hours postsurgery",{"measure":37,"description":38,"timeFrame":39},"Recovery quality","Chinese version of the 15-item Quality of Recovery Questionnaire (QoR-15); range 0-150, higher scores indicate better recovery","Assessed daily for three days postoperatively",{"measure":41,"description":42,"timeFrame":27},"Sleep quality","Richards-Campbell Sleep Questionnaire (RCSQ); higher mean scores indicate better sleep",{"measure":44,"description":45,"timeFrame":46},"Adverse events","Any adverse events during the study will be documented on the electronic medical records","through study completion, an average of 7 days",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":53,"maskingDescription":47,"whoMasked":54},"QUADRUPLE",[55,56,57,58],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Electroacupuncture combines traditional acupuncture with electrical stimulation at specific body points. Recent clinical studies have shown promising results for acupuncture-related techniques in managing perioperative neurocognitive disorders. However, the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty remains unexplored.This randomised controlled trial aims to evaluate the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty.",[61,68],{"label":62,"type":63,"description":64,"interventionNames":65},"Active electroacupuncture group","EXPERIMENTAL","Participants will receive 30 minutes of active electroacupuncture before anaesthesia induction. Experienced acupuncturists will administer electroacupuncture at Shenting (GV24, 0.5 cun \\[≈10 mm\\] above the anterior hairline midpoint) and bilateral Benshen (GB13, 3 cun \\[≈60 mm\\] lateral to GV24). After skin preparation and pad placement, patients will close their eyes. Needles will be inserted 20 to 24 mm into the subgaleal layer at a flat angle, then manually manipulated to elicit de qi sensations (eg, fullness, numbness and soreness). Electrodes attached to the needle handles will deliver stimulation for 30 minutes (2 Hz\u002F15 Hz frequency, 1 mA intensity) to cause mild skin movement without pain.",[66,67],"Device: Disposable acupuncture needles (0.30 × 75 mm)","Device: SDZ-V electroacupuncture devices",{"label":69,"type":70,"description":71,"interventionNames":72},"Sham electroacupuncture group","SHAM_COMPARATOR","Participants will receive 30 minutes of sham electroacupuncture before anaesthesia induction.The sham group will use non-acupuncture points: 20 mm above GV24 and 20 mm lateral to GB13. These points, in different dermatomes from true acupoints, minimise location-specific effects. The procedure will match the active group, excluding needle manipulation, de qi sensation and electrical output.",[73,67],"Device: Placebo needles (0.30 × 25 mm)",[75,80,84],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":47},"DEVICE","Disposable acupuncture needles (0.30 × 75 mm)","Disposable acupuncture needles (0.30 × 75 mm), placebo needles (0.30 × 25 mm) and SDZ-V electroacupuncture devices (Hwato, Suzhou Medical Supplies Factory Co Ltd, China) will be used. Electrodes attached to the needle handles will deliver stimulation for 30 minutes (2 Hz\u002F15 Hz frequency, 1 mA intensity) to cause mild skin movement without pain.",[62],{"type":76,"name":81,"description":82,"armGroupLabels":83,"otherNames":47},"Placebo needles (0.30 × 25 mm)","Disposable acupuncture needles (0.30 × 75 mm), placebo needles (0.30 × 25 mm) and SDZ-V electroacupuncture devices (Hwato, Suzhou Medical Supplies Factory Co Ltd, China) will be used. Sham electroacupuncture will use blunt-tipped placebo needles without current output, which retract into their handles to simulate skin insertion.",[69],{"type":76,"name":85,"description":78,"armGroupLabels":86,"otherNames":47},"SDZ-V electroacupuncture devices",[62,69],[88],{"name":89,"affiliation":90,"role":91},"Yusheng Yao, MD","Fujian Provincial Hospital, China","PRINCIPAL_INVESTIGATOR",[93],{"name":89,"role":94,"phone":95,"phoneExt":47,"email":96},"CONTACT","+86-13559939629","fjslyys@126.com",[98],{"facility":5,"status":47,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Fuzhou","Fujian","350001","China","CN",{"type":105,"coordinates":106},"Point",[107,108],119.30611,26.06139,{"lat":108,"lon":107},[111],{"name":89,"role":94,"phone":95,"phoneExt":47,"email":96},{"type":91,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"Yao Yusheng","Professor","100559467",false,"NCT06564506","Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty","Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty: a Multicentre Randomised Controlled Trial","Inclusion Criteria:\n\n* Aged 65-90 years\n* American Society of Anaesthesiologists (ASA) physical status class II or III\n* Scheduled for elective unilateral total knee arthroplasty under general anesthesia\n\nExclusion Criteria:\n\n* Baseline dementia or Mini-Mental State Examination (MMSE) score below 24\n* Implanted electrical devices (eg, pacemakers, brain or spinal cord neurostimulator)\n* Infection or abscess at any selected acupuncture point\n* Severe hematopoietic or hemorrhagic disease\n* Severe audio-visual impairments or inability to communicate in Mandarin\n* Alcohol or illicit drug misuse disorder\n* Current use of sedatives, antidepressants or glucocorticoids\n* Received acupuncture or electroacupuncture within one month before surgery\n* Any condition deemed unsafe or unsuitable by the research team","ALL","65 Years","90 Years",{"count":125,"type":126},1460,"ESTIMATED","INTERVENTIONAL",[129],"NA","Electroacupuncture may improve cognitive function and altered consciousness, but its effect on postoperative delirium in older arthroplasty patients remains unexplored. This study aims to assess the efficacy of electroacupuncture in preventing postoperative delirium in older adults undergoing total knee arthroplasty.",[132],"Postoperative Delirium",[134,135,136,137],"Older adults","Electroacupuncture","Postoperative delirium","Total knee arthroplasty","NOT_YET_RECRUITING","2025-09-25",{"date":141,"type":142},"2025-09-26","ACTUAL",{"date":144,"type":126},"2025-11-10",{"date":146,"type":126},"2026-08-30",{"name":5,"class":6},1]