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

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05537155
• Other study ID #: 2022-220
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: March 2024

Study information

• Verified date: September 2022
• Source: Peking University First Hospital
• Contact: Dong-Xin Wang, MD, PhD
• Phone: 86(10) 83572784
• Email: wangdongxin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Delirium
• Older Patients
• Orthopedic Surgery
• Postoperative Delirium
• Treatment

Intervention

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.

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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijin	Bejing
China	Beijing Jishuitan Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain intensity	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.	Up to 5 days after enrollment
Other	Subjective sleep quality	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.	Up to 5 days after enrollment
Other	Non-delirium complications	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.	Up to 30 days after surgery
Other	All-cause mortality	All-cause mortality	Up to 30 days after surgery
Primary	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	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
Secondary	Time to first delirium resolution	Delirium resolution indicates no delirium episode for at least 24 hours.	Up to 5 days after enrollment
Secondary	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
Secondary	Length of hospital stay after surgery	Length of hospital stay after surgery	Up to 30 days after surgery
Secondary	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