Clinical trial NCT06564506: Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty
Official title: Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty: a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Delirium
Keywords: Older adults
Electroacupuncture
Postoperative delirium
Total knee arthroplasty
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 1460
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of postoperative delirium within the first three postoperative days
timeFrame: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days
Secondary outcomes:
measure: Delirium severity
timeFrame: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days
measure: Delirium subtypes
timeFrame: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days
measure: Cognitive function
timeFrame: At 1, 3, 6 and 12 months postoperatively
measure: Anxiety and depression
timeFrame: Assessed preoperatively and daily for three days postoperatively
measure: Postoperative pain
timeFrame: Assessed at 1, 3, 6, 12, 24, 36, 48, 60 and 72 hours postsurgery
measure: Postoperative morphine consumption
timeFrame: During 72 hours postsurgery
measure: Recovery quality
timeFrame: Assessed daily for three days postoperatively
measure: Sleep quality
timeFrame: Assessed preoperatively and daily for three days postoperatively
measure: Adverse events
timeFrame: through study completion, an average of 7 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital, China
name: Yusheng Yao, MD
role: PRINCIPAL_INVESTIGATOR
References: