Effects of TEAS on POCD

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: Recruiting
• Conditions: Post-operative Cognitive Dysfunction
• Intervention / Treatment: Procedure: Transcutaneous electrical acupoint stimulation

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: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Tian; Phone Number: 86-21-68383702; Email: vaseline2001@hotmail.com

Study Locations

• China
  • Shanghai, China, 200127
    • Recruiting
    • Renji Hospital
    • Contact: Jie Tian; Phone Number: 86-21-68383702; Email: vaseline2001@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
the incidence of POCD	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

Outcome Measure	Measure Description	Time Frame
the incidence of POCD	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	whether the patients develop delirium will be analyzed with CAM	from Day 1 to Day 7 post-surgery
serum IL-1β level	an inflammatory mediator that reflects systemic inflammation	at Day 1 post-surgery
serum IL-6 level	an inflammatory mediator that reflects systemic inflammation	at Day 1 post-surgery
serum TNF-α level	an inflammatory mediator that reflects systemic inflammation	at Day 1 post-surgery
serum MMP9 level	an inflammatory mediator that reflects systemic inflammation	at Day 1 post-surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2021
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): April 30, 2022

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (ACTUAL): April 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID 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