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

Fujian Provincial Hospital

Status: Not yet enrolling

Conditions: Postoperative Delirium

Treatments: Device: Disposable acupuncture needles (0.30 × 75 mm); Device: Placebo needles (0.30 × 25 mm); Device: SDZ-V electroacupuncture devices

Study type: Interventional

Funder types: Other

Identifiers

NCT06564506

K2023-02-004/02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,460 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Severe audio-visual impairments or inability to communicate in Mandarin
• Alcohol or illicit drug misuse disorder
• Current use of sedatives, antidepressants or glucocorticoids
• Received acupuncture or electroacupuncture within one month before surgery
• Any condition deemed unsafe or unsuitable by the research team

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,460 participants in 2 patient groups

Active electroacupuncture group

Experimental group

Description:

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/15 Hz frequency, 1 mA intensity) to cause mild skin movement without pain.

Treatment:

Device: SDZ-V electroacupuncture devices

Device: Disposable acupuncture needles (0.30 × 75 mm)

Sham electroacupuncture group

Sham Comparator group

Description:

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.

Treatment:

Device: SDZ-V electroacupuncture devices

Device: Placebo needles (0.30 × 25 mm)