Postoperative delirium
Conditions
Interventions
Experimental group:Active transcutaneous auricular vagus nerve stimulation (active taVNS)
Control group:Sham transcutaneous auricular vagus nerve stimulation (sham taVNS)
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years old; 2. Scheduled for laparoscopic radical resection of gastrointestinal malignancies under general anesthesia; 3. ASA classification: II-III grade; 4. Preoperative MMSE score: illiterate >= 17 points, primary school education >= 20 points, junior high school or above >= 24 points; 5. Voluntary participation and signing of informed consent form.
Exclusion criteria
Exclusion criteria: 1.Abnormal auricular anatomy, or skin damage and infection in the concha; 2.Preoperative delirium; 3.Current or previous neuropsychiatric disorders (e.g., traumatic brain injury, brain tumor, cerebrovascular accident, epilepsy, major depressive disorder, or schizophrenia); 4.History of craniocerebral surgery; 5.Severe cardiovascular diseases (e.g., severe sinus bradycardia or atrioventricular block, NYHA functional class >= 3); 6.Severe respiratory diseases (e.g., respiratory failure); 7.Severe hepatic or renal dysfunctions (e.g., Child–Pugh class C, eGFR < 45 mL / min / 1.73 m^2); 8.Severe visual or hearing impairments, or inability to communicate; 9.Alcohol or substance abuse; 10.Presence of implantable electrical stimulation devices (e.g., cardiac pacemaker); 11.Refusal to participate, or enrollment in another clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium within 3 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of delirium within 7 days after surgery;Postoperative hospital stay;Subtypes of delirium;Severity of delirium;Time to first onset and duration of delirium;Pain score;Postoperative inflammatory markers;Postoperative analgesic pump consumption;Incidence of delayed neurocognitive recovery;Sleep quality score;Gastrointestinal function score;Adverse events;Nausea and vomiting score;Anxiety score;Depression score;Fatigue score;Quality of recovery score;Number of postoperative rescue analgesia;Time to first postoperative flatus;Time to first tolerance of oral intake after surgery;Time to first postoperative ambulation; | — |
Countries
China
Contacts
Public ContactJunli Cao
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed