Postoperative Delirium
Conditions
Keywords
Older adults, Electroacupuncture, Postoperative delirium, Total knee arthroplasty
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.
Interventions
DEVICEDisposable 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.
DEVICEPlacebo 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.
DEVICESDZ-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.
Sponsors
Fujian Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Adverse events | through study completion, an average of 7 days | Any adverse events during the study will be documented on the electronic medical records |
| Postoperative morphine consumption | During 72 hours postsurgery | Cumulative morphine use and rescue analgesia recorded over 72 hours postsurgery |
Countries
China
Contacts
Primary ContactYusheng Yao, MD
Outcome results
None listed