Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty

Not Applicable

Not yet recruiting

• Conditions: Postoperative Delirium

• 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.

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-21
• Status Verified: 2024-09
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-09-26
• Study Start: 2025-11-10
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
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
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
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
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