Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery
Primary Purpose
Older Patients, Orthopedic Surgery, Postoperative Delirium
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Buccal acupuncture in addition to routine care
Routine care
Sponsored by
About this trial
This is an interventional treatment trial for Older Patients focused on measuring Older patients, Orthopedic surgery, Postoperative delirium, Buccal acupuncture, Treatment effects
Eligibility Criteria
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.
Sites / Locations
- Beijing Jishuitan Hospital
- Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Buccal acupuncture
Routine care
Arm Description
Buccal acupuncture will be performed in addition to routine care.
Routine care will be provided.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Time to first delirium resolution
Delirium resolution indicates no delirium episode for at least 24 hours.
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.
Length of hospital stay after surgery
Length of hospital stay 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.
Full Information
NCT ID
NCT05537155
First Posted
September 9, 2022
Last Updated
September 9, 2022
Sponsor
Peking University First Hospital
Collaborators
Beijing Jishuitan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05537155
Brief Title
Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery
Official Title
Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
Beijing Jishuitan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older Patients, Orthopedic Surgery, Postoperative Delirium, Acupuncture, Treatment
Keywords
Older patients, Orthopedic surgery, Postoperative delirium, Buccal acupuncture, Treatment effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Buccal acupuncture
Arm Type
Experimental
Arm Description
Buccal acupuncture will be performed in addition to routine care.
Arm Title
Routine care
Arm Type
Active Comparator
Arm Description
Routine care will be provided.
Intervention Type
Procedure
Intervention Name(s)
Buccal acupuncture in addition to routine care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of delirium-free days within 5 days
Description
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.
Time Frame
Up to 5 days after enrollment
Secondary Outcome Measure Information:
Title
Delirium severity within 5 days
Description
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 Frame
Up to 5 days after enrollment
Title
Time to first delirium resolution
Description
Delirium resolution indicates no delirium episode for at least 24 hours.
Time Frame
Up to 5 days after enrollment
Title
Delirium subtype
Description
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.
Time Frame
Up to 5 days after enrollment
Title
Length of hospital stay after surgery
Description
Length of hospital stay after surgery
Time Frame
Up to 30 days after surgery
Title
Quality of life at 30 days after surgery
Description
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.
Time Frame
At 30 days after surgery
Other Pre-specified Outcome Measures:
Title
Pain intensity
Description
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.
Time Frame
Up to 5 days after enrollment
Title
Subjective sleep quality
Description
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.
Time Frame
Up to 5 days after enrollment
Title
Non-delirium complications
Description
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.
Time Frame
Up to 30 days after surgery
Title
All-cause mortality
Description
All-cause mortality
Time Frame
Up to 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Xin Wang, MD, PhD
Phone
86(10) 83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Hong, MD
Phone
+86 17810265121
Email
honghong920066@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Jishuitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Da-Zhi Zhang, MD
Phone
+86 13717859402
Email
zhangdazhi23@sina.com
Facility Name
Peking University First Hospital
City
Beijin
State/Province
Bejing
ZIP/Postal Code
100034
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Phone
86(10) 83572784
Email
wangdongxin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hong Hong, MD
Phone
+86 17810265121
Email
honghong920066@sina.com
12. IPD Sharing Statement
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Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery
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