postoperative cognitive dysfunction
Conditions
Interventions
low-intensity stimulation group:Participants in the low-intensity stimulation group will undergo transcutaneous cervical vagal nerve stimulation at the left carotid triangle at an intensity of 3 mA.
Moderate-intensity stimulation group:Participants in the moderate-intensity stimulation group will undergo transcutaneous cervical vagus nerve stimulation at the left carotid triangle at an intensity
high-intensity stimulation group :Participants in the high-intensity stimulation group will undergo transcutaneous cervical vagus nerve stimulation at the left carotid triangle at an intensity of 9 mA
sham stimulation group:Participants in the sham stimulation group will receive sham stimulation to the left trapezius region at an intensity of 6 mA
Sponsors
Tianjin Third Central Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Voluntarily sign an informed consent form; 2) Patients with ASA Class I–III scheduled to undergo lower extremity orthopedic surgery under general anesthesia; 3) Estimated surgery duration: 2–4 hours; 4) Patients aged 65 years or older; gender; 5) Patients with a hospital stay of at least 3 days (including the day of surgery and the 2 days following surgery); 6) Patients without severe hearing or visual impairments, who are able to read and complete neurobehavioral tests.
Exclusion criteria
Exclusion criteria: 1) Participation in another clinical trial within 4 weeks prior to the start of this study; 2) Patients expected to die or be unable to undergo follow-up/testing within 3 months post-surgery; 3) MMSE score = 23; 4) History of dementia, psychiatric disorders, or any central nervous system disease; 5) Patients with severe cerebrovascular disease or a history of cerebrovascular disease accompanied by cognitive impairment; 6) Patients with a history of surgery or anatomical abnormalities in the anterior neck or trapezius muscle region; 7) Patients who have recently taken sedatives or antidepressants; 8) Patients with alcoholism or substance dependence; 9) Patients with severe hepatic or renal insufficiency; 10) Patients who have previously participated in this trial (patients who underwent two lower extremity orthopedic surgeries during the trial); 11) Patients deemed unsuitable for participation in the clinical trial based on the clinician’s comprehensive assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of POCD; | — |
Secondary
| Measure | Time frame |
|---|---|
| age;Gender;Education;ASA Classification;Comorbidity Severity Index (CCI);Patient functional status;Mood assessment: Beck Depression Inventory (BDI) score;State-Trait Anxiety Inventory (STAI) scores;Parameters relating to surgery, anaesthesia and hospitalisation;Plasma inflammatory markers;Cognitive function assessment;Cognitive-related proteins;Postoperative myocardial injury;Postoperative bowel function;Postoperative renal function; | — |
Countries
China
Contacts
Public ContactWang Haiyun
Tianjin Third Central Hospital
Outcome results
None listed