Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty
- Conditions
- Postoperative Delirium
- Interventions
- Device: Disposable acupuncture needles (0.30 × 75 mm)Device: Placebo needles (0.30 × 25 mm)Device: SDZ-V electroacupuncture devices
- Registration Number
- NCT06564506
- Lead Sponsor
- Fujian Provincial Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1460
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active electroacupuncture group SDZ-V electroacupuncture devices 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. Active electroacupuncture group Disposable acupuncture needles (0.30 × 75 mm) 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 Placebo needles (0.30 × 25 mm) 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. Sham electroacupuncture group SDZ-V electroacupuncture devices 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.
- Primary Outcome Measures
Name Time Method The incidence of postoperative delirium within the first three postoperative days 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.
- Secondary Outcome Measures
Name Time Method Cognitive function At 1, 3, 6 and 12 months postoperatively Abbreviated Mental Test Score (AMTS) via telephone at 1, 3, 6 and 12 months postoperatively
Delirium severity At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days Delirium Rating Scale-Revised-98 (DRS-R-98); range 0-39, higher scores indicate greater severity
Postoperative pain Assessed at 1, 3, 6, 12, 24, 36, 48, 60 and 72 hours postsurgery 11-point Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at rest and movement
Postoperative morphine consumption During 72 hours postsurgery Cumulative morphine use and rescue analgesia recorded over 72 hours postsurgery
Recovery quality Assessed daily for three days postoperatively Chinese version of the 15-item Quality of Recovery Questionnaire (QoR-15); range 0-150, higher scores indicate better recovery
Sleep quality Assessed preoperatively and daily for three days postoperatively Richards-Campbell Sleep Questionnaire (RCSQ); higher mean scores indicate better sleep
Delirium subtypes At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days Richmond Agitation Sedation Scale (RASS); hypoactive (-3 to 0), hyperactive (+1 to +4) or mixed
Adverse events through study completion, an average of 7 days Any adverse events during the study will be documented on the electronic medical records
Anxiety and depression Assessed preoperatively and daily for three days postoperatively 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
Trial Locations
- Locations (1)
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China