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According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving taVNS.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications.
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of taVNS to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive "standard-stimulation parameters" of taVNS(25HZ,250μs), while the control group will receive "low-stimulation parameters" of taVNS(1HZ,250μs). The main outcome measure of the study was the incidence of POD within 5 days after surgery. Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS with "standard-stimulation parameters" | Active Comparator | with a current stimulation frequency of 25 Hz and a pulse width of 250 μs |
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| taVNS with "low-stimulation parameters" | Sham Comparator | with a current stimulation frequency of 1 Hz and a pulse width of 250 μs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transauricular auricular vagus nerve stimulation | Device | transauricular auricular vagus nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of POD at discharge or within 5 days postoperatively | POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge | At discharge or within 5 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delayed cognitive recovery during hospitalization | The MMSE/MoCA scale were used for evaluation | Day 1 before surgery, day 5 after surgery, day 90 after surgery |
| Incidence of neurocognitive dysfunction at 90 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruquan Han, MD | Contact | 8610-59976660 | ruquan.han@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40447430 | Derived | Wu Y, Hou X, Wang T, Wang X, Zhang K, Liang F, Jian M, Wang B, Liu H, Wang A, Han R. Transcutaneous auricular vagus nerve stimulation prevents postoperative delirium in elderly patients (VNSTAR): protocol for a multicentre, randomised controlled trial. BMJ Open. 2025 May 30;15(5):e099736. doi: 10.1136/bmjopen-2025-099736. |
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assessed by AMTS scale
| on the 90 days |
| Degree of decline in activities of daily living at 90 days postoperatively | use the IADL score | on the 90 days |
| All-cause mortality | on the 90 days |
| Incidence of unplanned ICU or HDU admissions | on the 90 days |
| Proportion of patients requiring higher levels of care postdischarge, specifically long-term care. | on the 90 days |
| Length of hospital stay | on the 90 days |
| Delirium severity | Delirium severity was assessed via the 3D-CAM-S scale. 3D-CAM-S scale: The total score is 7, with 0 being normal, 1 being mild delirium, 2 being moderate delirium, and 3-7 being severe delirium | At discharge or within 5 days postoperatively |