Effects of TEAS on POCD

NCT04338555 | Completed

• 1 other identifier: AES20200407
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-operative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• the incidence of POCD

  at Day 30 post-surgery

• the incidence of delirium

  from Day 1 to Day 7 post-surgery

• serum IL-1β level

  at Day 1 post-surgery

• serum IL-6 level

  at Day 1 post-surgery

• serum TNF-α level

  at Day 1 post-surgery

Study Arms (2)

TEAS group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

Transcutaneous electrical acupoint stimulation PROCEDURE

TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30 min every hour during the surgery.

TEAS group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

Location

Study Officials

• Jie Tian

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 8, 2020
• Study Start: October 14, 2021
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

CN (1)