Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty
NCT Number: NCT06564506
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Postoperative Delirium
Interventions: DEVICE: Disposable acupuncture needles (0.30 × 75 mm)|DEVICE: Placebo needles (0.30 × 25 mm)|DEVICE: SDZ-V electroacupuncture devices
Sponsor: Fujian Provincial Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 1460
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-02
Completion Date: 2026-08-30
Locations: Fujian Provincial Hospital, Fuzhou, Fujian, 350001, China

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: Delirium severity, Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity, At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days|Delirium subtypes, Richmond Agitation Sedation Scale (RASS); hypoactive (-3 to 0), hyperactive (+1 to +4) or mixed, At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days|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|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|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|Postoperative morphine consumption, Cumulative morphine use and rescue analgesia recorded over 72 hours postsurgery, During 72 hours postsurgery|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|Sleep quality, Richards-Campbell Sleep Questionnaire (RCSQ); higher mean scores indicate better sleep, Assessed preoperatively and daily for three days postoperatively|Adverse events, Any adverse events during the study will be documented on the electronic medical records, through study completion, an average of 7 days