Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorFujian Provincial Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Disposable acupuncture needles (0.30 × 75 mm)

    Device

    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.

  • Placebo needles (0.30 × 25 mm)

    Device

    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.

  • SDZ-V electroacupuncture devices

    Device

    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.

Treatment groups

1,460 Participants
are divided into 2 treatment groups
Group A: Active electroacupuncture groupExperimental treatment 2 interventions
Group B: Sham electroacupuncture groupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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