Post-operative Cognitive Dysfunction
Conditions
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.
Interventions
PROCEDURETranscutaneous electrical acupoint stimulation
TEAS group will receive electrical stimulation of acupoints at Neiguan and Shenmen points for 30 min every hour during the surgery.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of POCD | 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
| Measure | Time frame | Description |
|---|---|---|
| the incidence of delirium | from Day 1 to Day 7 post-surgery | whether the patients develop delirium will be analyzed with CAM |
| serum IL-1β level | at Day 1 post-surgery | an inflammatory mediator that reflects systemic inflammation |
| the incidence of POCD | 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 |
| serum TNF-α level | at Day 1 post-surgery | an inflammatory mediator that reflects systemic inflammation |
| serum MMP9 level | at Day 1 post-surgery | an inflammatory mediator that reflects systemic inflammation |
| serum IL-6 level | at Day 1 post-surgery | an inflammatory mediator that reflects systemic inflammation |
Countries
China
Outcome results
None listed