Postoperative Delirium Clinical Trial
Official title:
Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery: a Randomized Controlled Trial
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijin | Bejing |
China | Beijing Jishuitan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | Beijing Jishuitan Hospital |
China,
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* Note: There are 21 references in all — Click here to view all references
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 |
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