Effects of TEAS on POCD
Primary Purpose
Post-operative Cognitive Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous electrical acupoint stimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Post-operative Cognitive Dysfunction
Eligibility Criteria
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.
Sites / Locations
- Renji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TEAS group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
the incidence of delirium
whether the patients develop delirium will be analyzed with CAM
serum IL-1β level
an inflammatory mediator that reflects systemic inflammation
serum IL-6 level
an inflammatory mediator that reflects systemic inflammation
serum TNF-α level
an inflammatory mediator that reflects systemic inflammation
serum MMP9 level
an inflammatory mediator that reflects systemic inflammation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04338555
Brief Title
Effects of TEAS on POCD
Official Title
Effects of Transcutanclus Electrical Acupoint Stimulation on Postoperative Cognitive Dysfunction in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Cognitive Dysfunction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TEAS group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous electrical acupoint stimulation
Intervention Description
TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30 min every hour during the surgery.
Primary Outcome Measure Information:
Title
the incidence of POCD
Description
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
Time Frame
at Day 7 post-surgery
Secondary Outcome Measure Information:
Title
the incidence of POCD
Description
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
Time Frame
at Day 30 post-surgery
Title
the incidence of delirium
Description
whether the patients develop delirium will be analyzed with CAM
Time Frame
from Day 1 to Day 7 post-surgery
Title
serum IL-1β level
Description
an inflammatory mediator that reflects systemic inflammation
Time Frame
at Day 1 post-surgery
Title
serum IL-6 level
Description
an inflammatory mediator that reflects systemic inflammation
Time Frame
at Day 1 post-surgery
Title
serum TNF-α level
Description
an inflammatory mediator that reflects systemic inflammation
Time Frame
at Day 1 post-surgery
Title
serum MMP9 level
Description
an inflammatory mediator that reflects systemic inflammation
Time Frame
at Day 1 post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Tian
Phone
86-21-68383702
Email
vaseline2001@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Tian
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Tian
Phone
86-21-68383702
Email
vaseline2001@hotmail.com
12. IPD Sharing Statement
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Effects of TEAS on POCD
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