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Postoperative delirium is with increased incidence in elderly patients. Previous studies have shown that acupuncture related techniques could induce protection against brain ischemia and improve outcome after cerebral diseases. In this study the effect of transcutaneous electrical acupoint stimulation combined with auricular acupressure on postoperative delirium will be evaluated.
Postoperative delirium (POD) is an acute neurological disorder that commonly happens between postoperative days 1 and 3 and more common reported in elderly patients. The rate of delirium differs depending on the patients' characteristics, surgery types and setting of health care. The prevalence of delirium range from 18% to 35 % in a general medical service, and up to half of older patients postoperatively. It has been documented that POD is associated with an increase in mortality and morbidity, increased use of hospital resources, and higher cost of health care. The conventional preventive methods for delirium have focused on minimization or elimination of the predisposing and precipitating factors. Yet, few effective therapies are available for treating POD. New treatments are needed to reduce the prevalence and severity of delirium.
Complementary therapies, particularly acupuncture, have gained increasing attention for their possible value in the prevention and treatment of neurological disorders. Both basic and clinical studies have suggested that acupuncture may be beneficial to postoperative delirium. In functional MRI studies of healthy subjects and nervous system dysfunction patients, acupuncture has been shown to stimulate hippocampus, amygdala and insula, areas of the brain associated with memory, cognition and emotion.
In the clinical, TEAS has been reported to be effective in alleviating delirium in elderly patients with silent lacunar infarction. Evidence also showed that auricular acupunctures are efficacious for preventing postoperative agitation in geriatric patients
Given evidences of the possible efficacy of TEAS and auricular acupressure, we aim to do a 2-arm, randomized, controlled, single-blinded, pragmatic trial to investigate whether transcutaneous electrical acupoint stimulation combined with auricular acupressure is more effective in reducing postoperative delirium in elderly patients than usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Electrical stimulation will be given 30min before anesthesia and during surgery, auricular acupressure will be given in postoperative 3 days |
|
| Non-intervention group | Sham Comparator | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure | Device | Bilaterally Hegu (LI4), Neiguan (PC6) and Zusanli (ST36) will be used as the TEAS acupoints. Six acupoints (Shenmen, Point Zero, subcortex, heart, liver, and endocrine) located on ears will be used as the auricular acupressure points. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium | In postoperative 7 days or during patients stay in hospital if discharged within 7 days | From the end of surgery to 7 days after surgery |
| The severity of delirium | Assessed by memorial delirium assessment scale (MDAS) | From the end of surgery to 7 days after surgery or during patients stay in hospital if discharged within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Postoperative pain both at rest and with movement using Numeric Rating Scale (NRS) | 24h, 48h, 72h after surgery |
| S100B level | Serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhihong Lu | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30425466 | Background | Gao F, Zhang Q, Li Y, Tai Y, Xin X, Wang X, Wang Q. Transcutaneous electrical acupoint stimulation for prevention of postoperative delirium in geriatric patients with silent lacunar infarction: a preliminary study. Clin Interv Aging. 2018 Oct 24;13:2127-2134. doi: 10.2147/CIA.S183698. eCollection 2018. | |
| 19875431 | Background |
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The data of the study will be available for sharing after publishing, including data of the outcomes
The data of the study will be available for sharing after publishing on peer-reviewed journals, and will be available for 5 years
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
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transcutaneous electrical acupoint stimulation and auricular acupressure is given by an investigator who is not involved in anesthesia and outcome assessment
|
| Usual care | Other | Patients in this group only receive usual care developed by the study hospital |
|
| Before surgery and at the end of the surgery |
| Neuron-specific enolase level | Serum | Before surgery and at the end of the surgery |
| Brain-derived neurotrophic factor level | Serum | Before surgery and at the end of the surgery |
| Tumor necrosis factor-α level | Serum | Before surgery and at the end of the surgery |
| Interleukin- 6 level | Serum | Before surgery and at the end of the surgery |
| Aquaporin-4 level | Serum | Before surgery and at the end of the surgery |
| Postoperative sleep qualiy | Sleep quality within postoperative 4 days using Pittsburgh sleep quality index (PSQI) | 4 days after surgery |
| Length of stay in hospital after sugery | Days | From the day of suregry to discharge from surgery |
| Interleukin-10 level | Serum | Before surgery and at the end of the surgery |
| Matrix metalloproteinase 9 level | Serum | Before surgery and at the end of the surgery |
| Tau protain level | Serum | Before surgery and at the end of the surgery |
| β-Amyloid1-42 level | Serum | Before surgery and at the end of the surgery |
| Arai YC, Ito A, Hibino S, Niwa S, Ueda W. Auricular Acupunctures are Effective for the Prevention of Postoperative Agitation in Old Patients. Evid Based Complement Alternat Med. 2010 Sep;7(3):383-6. doi: 10.1093/ecam/nep172. Epub 2009 Oct 29. |
| 26676760 | Background | Scholz AF, Oldroyd C, McCarthy K, Quinn TJ, Hewitt J. Systematic review and meta-analysis of risk factors for postoperative delirium among older patients undergoing gastrointestinal surgery. Br J Surg. 2016 Jan;103(2):e21-8. doi: 10.1002/bjs.10062. Epub 2015 Dec 16. |
| 28231740 | Background | Matsumoto-Miyazaki J, Ushikoshi H, Miyata S, Miyazaki N, Nawa T, Okada H, Ojio S, Ogura S, Minatoguchi S. Acupuncture and Traditional Herbal Medicine Therapy Prevent Deliriumin Patients with Cardiovascular Disease in Intensive Care Units. Am J Chin Med. 2017;45(2):255-268. doi: 10.1142/S0192415X17500161. Epub 2017 Feb 23. |
| 35783617 | Derived | Fan Q, Lei C, Wang Y, Yu N, Wang L, Fu J, Dong H, Lu Z, Xiong L. Transcutaneous Electrical Acupoint Stimulation Combined With Auricular Acupressure Reduces Postoperative Delirium Among Elderly Patients Following Major Abdominal Surgery: A Randomized Clinical Trial. Front Med (Lausanne). 2022 Jun 15;9:855296. doi: 10.3389/fmed.2022.855296. eCollection 2022. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |