Effects of TEAS on POCD

Post-operative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04338555
• Other study ID #: AES20200407
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: October 2021
• Source: RenJi Hospital
• Contact: Jie Tian
• Phone: 86-21-68383702
• Email: vaseline2001[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: April 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Post-operative Cognitive Dysfunction
• Postoperative Cognitive Complications

Intervention

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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	the incidence of delirium	whether the patients develop delirium will be analyzed with CAM	from Day 1 to Day 7 post-surgery
Secondary	serum IL-1ß level	an inflammatory mediator that reflects systemic inflammation	at Day 1 post-surgery
Secondary	serum IL-6 level	an inflammatory mediator that reflects systemic inflammation	at Day 1 post-surgery
Secondary	serum TNF-a level	an inflammatory mediator that reflects systemic inflammation	at Day 1 post-surgery
Secondary	serum MMP9 level	an inflammatory mediator that reflects systemic inflammation	at Day 1 post-surgery