Using vagus nerve stimulation to prevent delirium in elderly patients after surgery
Transcutaneous Auricular Vagus Nerve Stimulation （taVNS）Prevents Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
This study is testing if a new way of stimulating the vagus nerve can help prevent confusion in older patients after they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1776 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06421077 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in preventing postoperative delirium (POD) in elderly patients undergoing anesthesia for surgery. Participants will be randomly assigned to receive either standard or low stimulation parameters of taVNS, and the incidence of POD will be evaluated within five days post-surgery. Secondary outcomes will assess cognitive impairment, mortality rates, adverse events, and length of hospital stay. The study aims to provide evidence for the safety and efficacy of taVNS in improving postoperative brain health.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older who are scheduled for surgeries lasting at least two hours and will have a postoperative hospital stay of four days or more.
Not a fit: Patients undergoing neurosurgery or cardiac surgery, emergency surgeries, or those with severe cognitive dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium in elderly patients, improving their recovery and overall health outcomes.
How similar studies have performed: While the use of vagus nerve stimulation is a novel approach in this context, similar studies have shown promising results in related areas of postoperative care.
Eligibility criteria
Show full inclusion / exclusion criteria
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 severe cognitive dysfunction affected perioperative cognitive function assessment * Severe sinus bradycardia, AVB of degree II and above, pacemaker placement
Where this trial is running
Beijing
- Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Ruquan Han, MD
- Email: ruquan.han@ccmu.edu.cn
- Phone: 8610-59976660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.