Back to resultsTranscutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction
Primary Purpose
Postoperative Cognitive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous electrical acupoint stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Cognitive Dysfunction focused on measuring POCD, TEAS, Gastrointestinal tumor
Eligibility Criteria
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.
Sites / Locations
- Northern Jiangsu People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transcutaneous electrical acupoint stimulation group
Control group
Arm Description
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.
In Control group, except the electronic stimulation was not applied, the treatment was the same as the Transcutaneous electrical acupoint stimulation group.
Outcomes
Primary Outcome Measures
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.
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.
C reactive protein
Assess the inflammatory reaction of the patient
C reactive protein
Assess the inflammatory reaction of the patient
C reactive protein
Assess the inflammatory reaction of the patient
Interleukin-6
Assess the inflammatory reaction of the patient
Interleukin-6
Assess the inflammatory reaction of the patient
Interleukin-6
Assess the inflammatory reaction of the patient
S100 calcium-binding protein β
Assess the inflammatory reaction of the patient
S100 calcium-binding protein β
Assess the inflammatory reaction of the patient
S100 calcium-binding protein β
Assess the inflammatory reaction of the patient
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04606888
First Posted
October 16, 2020
Last Updated
October 27, 2020
Sponsor
Subei People's Hospital of Jiangsu Province
1. Study Identification
Unique Protocol Identification Number
NCT04606888
Brief Title
Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction
Official Title
Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction in Geriatric Patients With Gastrointestinal Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Subei People's Hospital of Jiangsu Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
POCD, TEAS, Gastrointestinal tumor
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Transcutaneous electrical acupoint stimulation group and control group
Masking
ParticipantOutcomes Assessor
Masking Description
Patient don't konw which group they are in because we all told them that they will feel nothing during the intervention.
The outcomes assessor just to evaluate indicators, they don't know the specific content of the patient's experiment
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous electrical acupoint stimulation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In Control group, except the electronic stimulation was not applied, the treatment was the same as the Transcutaneous electrical acupoint stimulation group.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical acupoint stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mini-Mental State Examination score
Description
Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome.
Time Frame
In the morning of the day before operation
Title
Mini-Mental State Examination score
Description
Assess the cognitive function of the patient,the minimum value is 0,and the maximum value is 30, higher scores mean a better outcome.
Time Frame
Three days after operation
Title
C reactive protein
Description
Assess the inflammatory reaction of the patient
Time Frame
The day before operation.
Title
C reactive protein
Description
Assess the inflammatory reaction of the patient
Time Frame
The 1st day after the operation.
Title
C reactive protein
Description
Assess the inflammatory reaction of the patient
Time Frame
The 3rd day after the operation.
Title
Interleukin-6
Description
Assess the inflammatory reaction of the patient
Time Frame
The day before operation.
Title
Interleukin-6
Description
Assess the inflammatory reaction of the patient
Time Frame
The 1st day after the operation.
Title
Interleukin-6
Description
Assess the inflammatory reaction of the patient
Time Frame
The 3rd day after the operation.
Title
S100 calcium-binding protein β
Description
Assess the inflammatory reaction of the patient
Time Frame
The day before operation.
Title
S100 calcium-binding protein β
Description
Assess the inflammatory reaction of the patient
Time Frame
The 1st day after the operation.
Title
S100 calcium-binding protein β
Description
Assess the inflammatory reaction of the patient
Time Frame
The 3rd day after the operation.
Secondary Outcome Measure Information:
Title
Numeric Rating Scale score
Description
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Time Frame
The day before operation
Title
Numeric Rating Scale score
Description
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Time Frame
The day of operation
Title
Numeric Rating Scale score
Description
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Time Frame
The 1st day after the operation.
Title
Numeric Rating Scale score
Description
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Time Frame
The 2rd day after the operation.
Title
Numeric Rating Scale score
Description
Assess the pain score of the patient,the minimum value is 0,and the maximum value is 10, higher scores mean a worse outcome.
Time Frame
The 3nd day after the operation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daorong Wang, Ph.D.
Organizational Affiliation
Clinical Medical College of Yangzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Underlie results in a publication
IPD Sharing Time Frame
starting in October 2020
IPD Sharing Access Criteria
Study which was used to do meta analyse
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Transcutaneous Electrical Acupoint Stimulation for Postoperative Cognitive Dysfunction
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