Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery

Study Overview
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Brief Summary
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This study is designed to test the hypothesis that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

Detailed Description
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Delirium is an acute, transient central nervous system dysfunction characterized by fluctuating disturbances of attention, consciousness, and cognitive function. Delirium is common in older patients following surgery. The incidence of postoperative delirium ranges from 12.0% to 23.8% in older patients; the incidence of delirium is about 10.7-17.6% in older patients after joint replacement surgery. The occurrence of delirium is associated with worse outcomes, including increased early postoperative complications, prolonged hospital-stay, and increased in-hospital mortality, as well as long-term decline in cognitive function, quality of life, and survival duration. Clinical use of acupuncture has a long history in China. Buccal acupuncture therapy is a microneedle technique and provides treatment for systemic diseases by acupuncturing specific acupoints in the cheek. Acupuncture is also used for delirium treatment. Studies of older patients who developed delirium in internal medicine wards found that, compared with routine care alone, combining routine care with acupuncture relieved delirious symptoms and severity more efficaciously. However, evidence in this aspect is limited. We suppose that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

Official Title
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Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery: a Randomized Controlled Trial

Conditions
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Older Patients, Orthopedic Surgery, Postoperative Delirium, Acupuncture, Treatment

Intervention / Treatment
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* Procedure: Buccal acupuncture in addition to routine care
* Other: Routine care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Aged ≥65 years, but <90 years. After knee or hip replacement surgery. Diagnosed with delirium in the morning of enrollment. Exclusion criteria: Refuse to participate in the study. Presence of any contraindications to acupuncture, such as puncture site infections or platelet count ≤20×10^9/L. Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis. Inability to communicate due to coma, profound dementia, or language barrier, or inability to cooperate with treatment due to agitation. American Society of Anesthesiologists physical status grade ≥V, or estimated survival ≤24 h.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buccal acupuncture<br>Buccal acupuncture will be performed in addition to routine care. | Procedure: Buccal acupuncture in addition to routine care<br>* Acupuncture will be performed at a depth of 10 mm, with the needle retaining for 20 min, in addition to routine care. Bilateral acupoints include Tou, Shangjing, Jing, Bei, and Sanjiao. Unilateral acupoints is related to surgical sites and include Kuan in hip joint replacement surgery and Xi in knee joint replacement surgery. Patients with agitation will be treated first until agitation is controlled before acupuncture is performed.<br>|
| Active Comparator: Routine care<br>Routine care will be provided. | Other: Routine care<br>* Routing care includes the following: (1) remove the precipitating cause and treat the primary disease; and (2) supportive care, including reorientation and cognitive stimulation, sleep enhancement, early mobility and exercise, vision and hearing optimization, family engagement and empowerment, and early oral intake and nutrition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of delirium-free days within 5 days | Delirium will be assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the 3D-Confusion Assessment Method (3D-CAM) for non-intubated patients or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for intubated patients. | Up to 5 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium severity within 5 days | Delirium severity will be assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the Confusion Assessment Method-Severity (CAM-S). | Up to 5 days after enrollment | 
| Time to first delirium resolution | Delirium resolution indicates no delirium episode for at least 24 hours. | Up to 5 days after enrollment | 
| Delirium subtype | Each time before assessing delirium, sedation or agitation will be assessed using the Richmond Agitation Sedation Scale (RASS), with scores ranging from -5 (unarousable) to +4 (combative) and 0 indicates alert and calm. Patients with delirium will be classified into three subtypes: hyperactive (RASS consistently positive, from +1 to +4), hypoactive (RASS consistently neutral or negative, from -3 to 0), and mixed. | Up to 5 days after enrollment | 
| Length of hospital stay after surgery | Length of hospital stay after surgery | Up to 30 days after surgery | 
| Quality of life at 30 days after surgery | Quality of life will be assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function. | At 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older patients, Orthopedic surgery, Postoperative delirium, Buccal acupuncture, Treatment effects