Postoperative DeliriumNCT06564506
Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty
A study testing Disposable acupuncture needles (0.30 × 75 mm) and SDZ-V electroacupuncture devices in people with Postoperative Delirium, run by Fujian Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Disposable acupuncture needles (0.30 × 75 mm) and SDZ-V electroacupuncture devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,460 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Yusheng Yao, MD, +86-13559939629, fjslyys@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Delirium
- Being tested
- Disposable acupuncture needles (0.30 × 75 mm), Placebo needles (0.30 × 25 mm), SDZ-V electroacupuncture devices
- Keywords
- Older adults, Electroacupuncture, Postoperative delirium, Total knee arthroplasty
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 devicesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Placebo needles (0.30 × 25 mm); Device: SDZ-V electroacupuncture devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed daily for three days postoperatively
Sleep quality
Richards-Campbell Sleep Questionnaire (RCSQ); higher mean scores indicate better sleep
Measured: Assessed preoperatively and daily for three days postoperatively
Adverse events
Any adverse events during the study will be documented on the electronic medical records
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start10 Nov 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Yusheng, Fujian Provincial Hospital
- Investigators
- Yusheng Yao, MD, Principal investigator, Fujian Provincial Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564506
- Sponsor's protocol ID
- K2023-02-004/02
- Status last verified
- Sep 2024
- First submitted
- 19 Aug 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual deidentified participant data, the study protocol, and the statistical analysis plan can be accessed from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty: a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06564506
- Acronym / sponsor ID
- K2023-02-004/02
- Conditions
- Postoperative Delirium
- Keywords
- Older adults, Electroacupuncture, Postoperative delirium, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,460 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 10 Nov 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active electroacupuncture group | Experimental | Device: Disposable acupuncture needles (0.30 × 75 mm), Device: SDZ-V electroacupuncture devicesParticipants 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. |
| Sham electroacupuncture group | Sham comparator | Device: Placebo needles (0.30 × 25 mm), Device: SDZ-V electroacupuncture devicesParticipants 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active electroacupuncture group |
| 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. | Device | Sham electroacupuncture group |
| SDZ-V electroacupuncture devicesDisposable 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 | Active electroacupuncture group, Sham electroacupuncture group |
Primary outcome
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.
9 secondary outcomes
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 subtypes
Time frame: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days
Cognitive function
Time frame: At 1, 3, 6 and 12 months postoperatively
Anxiety and depression
Time frame: Assessed preoperatively and daily for three days postoperatively
Postoperative pain
Time frame: Assessed at 1, 3, 6, 12, 24, 36, 48, 60 and 72 hours postsurgery
Postoperative morphine consumption
Time frame: During 72 hours postsurgery
Recovery quality
Time frame: Assessed daily for three days postoperatively
Sleep quality
Time frame: Assessed preoperatively and daily for three days postoperatively
Adverse events
Time frame: through study completion, an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: Yes. The individual deidentified participant data, the study protocol, and the statistical analysis plan can be accessed from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusheng Yao, MD principal investigator
Fujian Provincial Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disposable acupuncture needles (0.30 × 75 mm) and SDZ-V electroacupuncture devices in people with Postoperative Delirium, run by Fujian Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yusheng Yao, MD (+86-13559939629, fjslyys@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.