Vagus Nerve Stimulation Clinical Trial
— VnstarOfficial title:
Transauricular Vagus Nerve Stimulation(taVNS)Improves Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving Transauricular vagal nerve stimulation.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.
Status | Recruiting |
Enrollment | 1438 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Age=65 years - Expected operation time= 2 hours - Postoperative hospital stay= 4 days - Sign the informed consent form Exclusion Criteria: - Neurosurgery or cardiac surgery - Emergency surgery within 6 hours of admission - End-stage disease with an expected survival of < 3 months - Preoperative intention cognitive impairment - Severe sinus bradycardia, AVB of degree II and above, pacemaker placement |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital, Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Incidence of cognitive decline | The MMSE scale and MoCA scale was used for evaluation | Day 1 before surgery, day 5 after surgery, day 90 after surgery | |
Secondary | All-cause mortality | on the 90 days | ||
Secondary | Incidence of unplanned ICU or HDU admissions | on the 90 days | ||
Secondary | Length of hospital stay | on the 90 days | ||
Secondary | Time of anesthesia recovery | Within 2 hours after the end of the surgery |
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