Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction

Study Overview
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Brief Summary
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Postoperative cognitive dysfunction (POCD) is one of the common complications of cancer patients after operation with a 8.9%-46.1% incidence, which severely affecting patients' postoperative recovery, increasing the medical cost, affecting the social function of patients, reducing the quality of life and increasing the mortality. Surgical trauma and perioperative pain can induce systematic inflammatory response and release systematic inflammatory mediators, which can enter the central nervous system (CNS) and lead to CNS inflammatory. In order to prevent the development of POCD among elder patients, the discovery of effective interventions reducing perioperative pain and inflammatory response is important. Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-invasive alternative to needle-based electro-acupuncture (EA). It combines the acupuncture and transcutaneous electrical nerve stimulation (TENS) by pasting the electrode piece on the acupoint instead of sticking the needles on the skin. TEAS can trigger the release of endogenous neurotransmitters, releasing endogenous analgesic substances, such as endorphins. TEAS also can reduce the intraoperative anesthetic consumption, postoperative pain score, postoperative nausea and vomiting (PONV), and improve the postoperative recovery of patients. Recently, TEAS was found to improve the cognitive function of geriatric patients with silent lacunar infarction. However, the current TEAS mainly focus on intraoperative. The effect of perioperative TEAS on POCD is not clear. Here, the effect of TEAS on POCD in geriatric adults undergoing radical resection of gastrointestinal tumors under general anesthesia was investigated to determine whether TEAS can decrease perioperative pain or inflammatory response to prevent the occurrence of POCD and to find out the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.

Detailed Description
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This study aims to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in elderly patients who were diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia and to determine the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.

Official Title
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Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction in Geriatric Patients With Gastrointestinal Tumor

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Device: Transcutaneous electrical acupoint stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 60 years or older; Patients were diagnosed with gastrointestinal tumor and received radical; resection of gastrointestinal tumors under general anesthesia in Subei people's hospital of Jiangsu province; The patients understood the research content and signed the informed consent form; American Society of Anesthesiology (ASA) score I-III; No frailty before operation; D-dimer was normal before the operation Exclusion Criteria: Patients with cognitive dysfunction before the operation or patients with previous history of cognitive dysfunction, dementia and delirium; Patients with a history of severe depression, schizophrenia and other mental and nervous system diseases or taking antipsychotic or antidepressant drugs in the past; Patients with severe hearing or visual impairment due to eye or ear diseases without assistive tools; Patients who are unable to communicate or have difficulty communicating; According to the definition of China chronic disease and its risk factors monitoring report (2010) (male average daily pure alcohol intake ≥ 61g, female average daily pure alcohol intake ≥ 41g, alcohol volume (g) = alcohol consumption (ML) × alcohol content% × 0.8); Patients who were hospitalized for three months or more before surgery or who had received surgical treatment within three months; Patients who can't take care of themselves or are physically disabled and unable to carry out nerve function test; Patients with severe heart, liver and renal failure; Patients with hypoxemia (blood oxygen saturation < 94%) more than 10 minutes during operation; Patients admitted to ICU after operation; Patients who quit or died due to noncooperation or sudden situation; Patients who already participate in other clinical studies which may influence this study; Patient who underwent emergency surgery; Patient had a history of recent or conventional acupuncture treatment.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 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
Interventional Model Description: Transcutaneous electrical acupoint stimulation group and control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous electrical acupoint stimulation group<br>Transcutaneous electrical acupoint stimulation group patients received Transcutaneous electrical acupoint stimulation (Neiguan [PC6], Yintang [GV 29], Zusanli [ST36]) for 30 min before the induction of anaesthesia until the end of the surgery and the night before operation, the first, second and third night after operation 30 min once a day with an altered frequency 2/100 Hz, disperse-dense waves, adjusted electricity intensity which was less than 10 mA. | Device: Transcutaneous electrical acupoint stimulation<br>* According to the traditional Chinese medicine 15,three acupuncture points were selected as the target points: bilateral Neiguan ,Yintang and bilateral Zusanli.. A transcutaneous electrical stimulator was used to provide an altered frequency 2/100 Hz,disperse-dense waves,and adjusted intensity which was less than 10mA.<br>|
| No Intervention: Control group<br>In Control group, except the electronic stimulation was not applied, the treatment was the same as the Transcutaneous electrical acupoint stimulation group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination score | Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome. | In the morning of the day before operation | 
| Mini-Mental State Examination score | Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome. | Three days after operation | 
| C reactive protein | Assess the inflammatory reaction of the patient | The day before operation. | 
| C reactive protein | Assess the inflammatory reaction of the patient | The 1st day after the operation. | 
| C reactive protein | Assess the inflammatory reaction of the patient | The 3rd day after the operation. | 
| Interleukin-6 | Assess the inflammatory reaction of the patient | The day before operation. | 
| Interleukin-6 | Assess the inflammatory reaction of the patient | The 1st day after the operation. | 
| Interleukin-6 | Assess the inflammatory reaction of the patient | The 3rd day after the operation. | 
| S100 calcium-binding protein β | Assess the inflammatory reaction of the patient | The day before operation. | 
| S100 calcium-binding protein β | Assess the inflammatory reaction of the patient | The 1st day after the operation. | 
| S100 calcium-binding protein β | Assess the inflammatory reaction of the patient | The 3rd day after the operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale score | Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome. | The day before operation | 
| Numeric Rating Scale score | Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome. | The day of operation | 
| Numeric Rating Scale score | Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome. | The 1st day after the operation. | 
| Numeric Rating Scale score | Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome. | The 2rd day after the operation. | 
| Numeric Rating Scale score | Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome. | The 3nd day after the operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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POCD, TEAS, Gastrointestinal tumor