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

NCT06564506 | Not Yet Recruiting DMC

• 1 other identifier: K2023-02-004/02
• Study Type: interventional
• Target: 1,460
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium

Keywords

Older adults; Electroacupuncture; Postoperative delirium; Total knee arthroplasty

Outcome Measures

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.

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

Secondary Outcomes (9)

• Delirium severity

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

• Delirium subtypes

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

• Cognitive function

  At 1, 3, 6 and 12 months postoperatively

• Anxiety and depression

  Assessed preoperatively and daily for three days postoperatively

• Postoperative pain

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

Study Arms (2)

Active electroacupuncture group

EXPERIMENTAL

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); Device: SDZ-V electroacupuncture devices

Sham electroacupuncture group

SHAM COMPARATOR

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

Interventions

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.

Active electroacupuncture group

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.

Sham electroacupuncture group

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.

Active electroacupuncture group; Sham electroacupuncture group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Yusheng Yao, MD

  Fujian Provincial Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yusheng Yao, MD

CONTACT

+86-13559939629; fjslyys@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: November 10, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 26, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from 3 months after publication, until 5 years.

Locations

CN (1)