About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 65-90 years
American Society of Anaesthesiologists (ASA) physical status class II or III
Scheduled for elective unilateral total knee arthroplasty under general anesthesia
Disqualifiers
Baseline dementia or Mini-Mental State Examination (MMSE) score below 24
Implanted electrical devices (eg, pacemakers, brain or spinal cord neurostimulator)
Infection or abscess at any selected acupuncture point
Severe hematopoietic or hemorrhagic disease
Trial design
Parallel
Treatments tested in this trial
Disposable acupuncture needles (0.30 × 75 mm)
DeviceDisposable 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.
Placebo needles (0.30 × 25 mm)
DeviceDisposable 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.
SDZ-V electroacupuncture devices
DeviceDisposable 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Delirium severity
Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity
Delirium subtypes
Richmond Agitation Sedation Scale (RASS); hypoactive (-3 to 0), hyperactive (+1 to +4) or mixed
Cognitive function
Abbreviated Mental Test Score (AMTS) via telephone 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
Sponsors and contacts
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