Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty
NCT ID: NCT06564506
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
1460 participants
INTERVENTIONAL
2025-11-10
2026-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Electroacupuncture on the Incidence of Postoperative Delirium in Elderly Patients Undergoing the Major Surgery
NCT03606941
The Effect of 40 Hz Transcranial Stimulation on the Incidence of Delirium After Total Hip Replacement or Total Knee Replacement Arthroplasty in Elderly Patients.
NCT06522087
Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
NCT06542978
Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
NCT05535985
Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery
NCT05537155
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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 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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* American Society of Anaesthesiologists (ASA) physical status class II or III
* Scheduled for elective unilateral total knee arthroplasty under general anesthesia
Exclusion Criteria
* 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
65 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fujian Provincial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yao Yusheng
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yusheng Yao, MD
Role: PRINCIPAL_INVESTIGATOR
Fujian Provincial Hospital, China
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fujian Provincial Hospital
Fuzhou, Fujian, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
K2023-02-004/02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.