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

Not Applicable

Not yet recruiting

• Conditions: Older Patients; Orthopedic Surgery; Acupuncture; Postoperative Delirium; Treatment
• Interventions: Other: Routine care; Procedure: Buccal acupuncture in addition to routine care

• Registration Number: NCT05537155
• Lead Sponsor: Peking University First Hospital

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.

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 Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study First Posted: 2022-09-13
• Last Update Posted: 2022-09-13
• Study Start: 2022-10
• Primary Completion: 2024-01
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine care	Routine care	Routine care will be provided.
Buccal acupuncture	Buccal acupuncture in addition to routine care	Buccal acupuncture will be performed in addition to routine care.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to first delirium resolution	Up to 5 days after enrollment	Delirium resolution indicates no delirium episode for at least 24 hours.
Length of hospital stay after surgery	Up to 30 days after surgery	Length of hospital stay after surgery
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.
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).
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.

Trial Locations

Locations (2)

Beijing Jishuitan Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijin, Bejing, China