Effects of TEAS on POCD

July 2, 2024 updated by: Jie Tian, RenJi Hospital

Effects of Transcutanclus Electrical Acupoint Stimulation on Postoperative Cognitive Dysfunction in Elderly Patients

Patients undergoing elective orthopedics, urology, and general surgery will be included and randomly allocated to TEAS group or control group . After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points. For patients in the control group, the electrodes will be only attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. The primary outcome is the incidence of POCD at Day 7 after surgery. The secondary outcomes include the incidence of POD during post-operative days 1-7, the incidence of POCD at Day 30 after surgery, and the serum levels of cytokines, including IL-1β、IL-6、TNF-α、MMP9 on Day 1 after surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will enroll 110 patients who are older than 60 years old and will have elective orthopedics, urology, or general surgeries under general anesthesia. Patients will be randomly assigned to TEAS group and control group. After routine anesthesia induction and tracheal intubation, patients in TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30min every hour. In other words, the patients will receive TEAS stimulation for 30min, then no stimulation for 30min, then stimulation for another 30min, etc, until the end of the surgery. For patients in the control group, the electrodes will be only attached to the corresponding sites, with no TEAS electrical stimulation given during the operation. The primary outcome is the incidence of POCD at Day 7 after surgery. The secondary outcomes include the incidence of POD during post-operative days 1-7, the incidence of POCD at Day 30 after surgery, and the serum levels of cytokines, including IL-1β、IL-6、TNF-α、MMP9 on Day 1 after surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China, 200127
        • Renji hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≧ 60 years old;
  2. communicate normally；
  3. ASA Physical Status 1-2;
  4. Patients will have elective orthopedics, urology or general surgeries under general anesthesia;
  5. With an estimated surgery time of more than 2h;
  6. Agree to participate the trial.

Exclusion Criteria:

  1. Patients with brain diseases or history of brain diseases;
  2. Preoperative diagnosis of cognitive impairment by subtle mental state (MMSE) less than 24 points;
  3. Patients with history of neurological and psychological disorders including AD, stroke, and psychosis;
  4. Severe hearing or visual impairment, illiteracy;
  5. preoperative systolic blood pressure >190mmHg, or diastolic blood pressure >100mmHg;
  6. Disagree to participate in this research;
  7. Have used other medical electronic devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TEAS group
Patients in the TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30min every hour. The stimulation will repeat until the end of surgery.
Procedure: Transcutaneous electrical acupoint stimulation
TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30 min every hour during the surgery.
No Intervention: control group
In patients from the control group, the electrodes will only be attached to the corresponding sites, with no TEAS electrical stimulation given during the operation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the incidence of POCD
Time Frame: at Day 7 post-surgery
cognitive function of the patients will be analyzed with MMSE, Digital breadth, Number symbol, Visual regeneration, Color word conversion, Color Trail Marking Test (PartB) and CAM, and reflected by Z score with the following formula: Z=（Xafter-Xbefore）/SDbefore
at Day 7 post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the incidence of POCD
Time Frame: at Day 30 post-surgery
cognitive function of the patients will be analyzed with MMSE, Digital breadth, Number symbol, Visual regeneration, Color word conversion, Color Trail Marking Test (PartB) and CAM, and reflected by Z score with the following formula: Z=（Xafter-Xbefore）/SDbefore
at Day 30 post-surgery
the incidence of delirium
Time Frame: from Day 1 to Day 7 post-surgery
whether the patients develop delirium will be analyzed with CAM
from Day 1 to Day 7 post-surgery
serum IL-1β level
Time Frame: at Day 1 post-surgery
an inflammatory mediator that reflects systemic inflammation
at Day 1 post-surgery
serum IL-6 level
Time Frame: at Day 1 post-surgery
an inflammatory mediator that reflects systemic inflammation
at Day 1 post-surgery
serum TNF-α level
Time Frame: at Day 1 post-surgery
an inflammatory mediator that reflects systemic inflammation
at Day 1 post-surgery
serum MMP9 level
Time Frame: at Day 1 post-surgery
an inflammatory mediator that reflects systemic inflammation
at Day 1 post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jie Tian, Renji hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AES20200407

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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