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

Sponsor

Peking University First Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05537155

Collaborator

Beijing Jishuitan Hospital (Other)

112

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Older Patients Orthopedic Surgery Postoperative Delirium Acupuncture Treatment	Procedure: Buccal acupuncture in addition to routine care Other: Routine care	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buccal acupuncture Buccal acupuncture will be performed in addition to routine care.	Procedure: Buccal acupuncture in addition to routine care 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.
Active Comparator: Routine care Routine care will be provided.	Other: Routine care 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.

Arm

Intervention/Treatment

Experimental: Buccal acupuncture

Buccal acupuncture will be performed in addition to routine care.

Procedure: Buccal acupuncture in addition to routine care

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.

Active Comparator: Routine care

Routine care will be provided.

Other: Routine care

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.

Outcome Measures

Primary Outcome Measures

Number of delirium-free days within 5 days [Up to 5 days after enrollment]
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.

Secondary Outcome Measures

Delirium severity within 5 days [Up to 5 days after enrollment]
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).
Time to first delirium resolution [Up to 5 days after enrollment]
Delirium resolution indicates no delirium episode for at least 24 hours.
Delirium subtype [Up to 5 days after enrollment]
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.
Length of hospital stay after surgery [Up to 30 days after surgery]
Length of hospital stay after surgery
Quality of life at 30 days after surgery [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.

Other Outcome Measures

Pain intensity [Up to 5 days after enrollment]
Pain intensity, both at rest and with movement, will be assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the numeric rating scale (NRS), an 11-point scale where 0 indicates no pain and 10 the worst pain.
Subjective sleep quality [Up to 5 days after enrollment]
Subjective sleep quality will be assessed once daily (8:00-10:00 am) with the numeric rating scale (NRS), an 11-point scale where 0 indicates the best possible sleep and 10 the worst possible sleep.
Non-delirium complications [Up to 30 days after surgery]
Defined as new-onset medical conditions other than delirium that were deemed harmful and required therapeutic intervention, i.e., grade II or higher on the Clavien-Dindo classification.
All-cause mortality [Up to 30 days after surgery]
All-cause mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.