Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusheng Yao, MD | Contact | +86-13559939629 | fjslyys@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yusheng Yao, MD | Fujian Provincial Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Hospital | Fuzhou | Fujian | 350001 | China |
The individual deidentified participant data, the study protocol, and the statistical analysis plan can be accessed from the corresponding author upon reasonable request.
from 3 months after publication, until 5 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
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 |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided