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NCT Number: NCT06564506

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

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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The incidence of postoperative delirium within the first three postoperative days

    Time frame: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three 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

  1. Delirium severity

    Time frame: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days

    Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity

  2. Delirium subtypes

    Time frame: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days

    Richmond Agitation Sedation Scale (RASS); hypoactive (-3 to 0), hyperactive (+1 to +4) or mixed

  3. Cognitive function

    Time frame: At 1, 3, 6 and 12 months postoperatively

    Abbreviated Mental Test Score (AMTS) via telephone at 1, 3, 6 and 12 months postoperatively

  4. Anxiety and depression

    Time frame: Assessed preoperatively and daily for three days postoperatively

    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

  5. Postoperative pain

    Time frame: Assessed at 1, 3, 6, 12, 24, 36, 48, 60 and 72 hours postsurgery

    11-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at rest and movement

  6. Postoperative morphine consumption

    Time frame: During 72 hours postsurgery

    Cumulative morphine use and rescue analgesia recorded over 72 hours postsurgery

  7. Recovery quality

    Time frame: Assessed daily for three days postoperatively

    Chinese version of the 15-item Quality of Recovery Questionnaire (QoR-15); range 0-150, higher scores indicate better recovery

  8. Sleep quality

    Time frame: Assessed preoperatively and daily for three days postoperatively

    Richards-Campbell Sleep Questionnaire (RCSQ); higher mean scores indicate better sleep

  9. Adverse events

    Time frame: through study completion, an average of 7 days

    Any adverse events during the study will be documented on the electronic medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Yusheng Yao, MD

CONTACT

[email protected]

+86-13559939629

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Official study title

Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty: a Multicentre Randomised Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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