Acupoint Stimulation Improve Postoperative Delirium in Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Transcutaneous Acupoint Electrical Acupoint Stimulation Combined With Auricular Acupressure on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery: a Pragmatic Randomized Clinical Trial

Conditions
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Postoperative Complications, Postoperative Delirium

Intervention / Treatment
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* Device: Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective abdominal surgery under general anesthesia American Society of Anesthesiologists (ASA) physical status class≤Ⅲ; Mini mental state examination (MMSE) score>20; Exclusion Criteria: Implantation of a cardiac pacemaker, cardioverter, defibrillator or internal hearing aids; Documented alcohol or substance abuse within 3 months before surgery; Dermatological conditions or frail skin; Dysesthesia or infection over the acupoint stimulation skin area; Limb abnormalities; Allergy to ECG pads; Use of psychoactive medications; Severe visual or auditory impairment; Preoperative history of schizophrenia, epilepsy, parkinsonism, depression, or myasthenia gravis; Brain injury or neurosurgery.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Electrical stimulation will be given 30min before anesthesia and during surgery, auricular acupressure will be given in postoperative 3 days | Device: Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure<br>* 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.<br>|
| Sham Comparator: Non-intervention group<br>Usual care | Other: Usual care<br>* Patients in this group only receive usual care developed by the study hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Elderly patients, Transcutaneous acupoint electrical acupoint stimulation, Auricular acupressure