Skip to main content
OpenTrials
Completed

NCT Number: NCT04338555

Effects of TEAS on POCD

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital

Shanghai, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≧ 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. the incidence of delirium

    Time frame: from Day 1 to Day 7 post-surgery

    whether the patients develop delirium will be analyzed with CAM

  3. serum IL-1β level

    Time frame: at Day 1 post-surgery

    an inflammatory mediator that reflects systemic inflammation

  4. serum IL-6 level

    Time frame: at Day 1 post-surgery

    an inflammatory mediator that reflects systemic inflammation

  5. serum TNF-α level

    Time frame: at Day 1 post-surgery

    an inflammatory mediator that reflects systemic inflammation

  6. serum MMP9 level

    Time frame: at Day 1 post-surgery

    an inflammatory mediator that reflects systemic inflammation

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.