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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Device: Disposable acupuncture needles (0.30 × 75 mm); Device: SDZ-V electroacupuncture devices; Device: Placebo needles (0.30 × 25 mm)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 1460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yusheng Yao, MD; Phone Number: +86-13559939629; Email: fjslyys@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Provincial Hospital
      • Contact: Yusheng Yao, MD; Phone Number: +86-13559939629; Email: fjslyys@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active electroacupuncture group; 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.	Device: Disposable acupuncture needles (0.30 × 75 mm); 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.; Device: SDZ-V electroacupuncture devices; 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.
Sham Comparator: Sham electroacupuncture group; 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.	Device: SDZ-V electroacupuncture devices; 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.; Device: Placebo needles (0.30 × 25 mm); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium severity	Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity	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	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	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	Assessed preoperatively and daily for three days postoperatively
Postoperative pain	11-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at rest and movement	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	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	Assessed daily for three days postoperatively
Sleep quality	Richards-Campbell Sleep Questionnaire (RCSQ); higher mean scores indicate better sleep	Assessed preoperatively and daily for three days postoperatively
Adverse events	Any adverse events during the study will be documented on the electronic medical records	through study completion, an average of 7 days

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital
• Investigators: Principal Investigator: Yusheng Yao, MD, Fujian Provincial Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Older adults; Postoperative delirium; Electroacupuncture
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: K2023-02-004/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual deidentified participant data, the study protocol, and the statistical analysis plan can be accessed from the corresponding author upon reasonable request.
• IPD Sharing Time Frame: from 3 months after publication, until 5 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No