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To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study.
This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation(taVNS) to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transauricular Vagal Nerve Stimulation | Active Comparator |
| |
| Transauricular Vagal Nerve sham Stimulation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transauricular Vagal Nerve Stimulation | Device | Transauricular vagal nerve stimulation,Intervention group25Hz,Control group1Hz |
|
| Measure | Description | Time Frame |
|---|---|---|
| TaVNS tolerance | The proportion of subjects who completed all the expected interventions | 1-5 days after surgery |
| Incidence of adverse events | Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc | At discharge,an average of 2 weeks |
| 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 |
| Incidence of cognitive decline |
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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 |
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The MMSE scale and MoCA scale was used for evaluation |
| Day 1 before surgery, day 5 after surgery, day 90 after surgery |
| All-cause mortality | on the 90 days |
| Postoperative pain | VAS score | 1-5 days after surgery |
| Time of anesthesia recovery | Within 2 hours after the end of the surgery |