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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,460
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/15 Hz frequency, 1 mA intensity) to cause mild skin movement without pain.
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.
Fujian Provincial Hospital
Fuzhou, Fujian, China
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.
Time frame: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days
Delirium severity
Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessed preoperatively and daily for three days postoperatively
Postoperative pain
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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/15 Hz frequency, 1 mA intensity) to cause mild skin movement without pain.
11-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at rest and movement
Time frame: 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
Time frame: 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
Time frame: Assessed daily for three days postoperatively
Sleep quality
Richards-Campbell Sleep Questionnaire (RCSQ); higher mean scores indicate better sleep
Time frame: Assessed preoperatively and daily for three days postoperatively
Adverse events
Any adverse events during the study will be documented on the electronic medical records
Time frame: through study completion, an average of 7 days