Vagus Nerve Stimulation Clinical Trial
— Vnstar-IIaOfficial title:
Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
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 | TaVNS tolerance | The proportion of subjects who completed all the expected interventions | 1-5 days after surgery | |
Primary | Incidence of adverse events | Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc | At discharge,an average of 2 weeks | |
Secondary | 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 | Postoperative pain | VAS score | 1-5 days after surgery | |
Secondary | Time of anesthesia recovery | Within 2 hours after the end of the surgery |
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