Vagus Nerve Stimulation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
transauricular auricular vagus nerve stimulation
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of POD at discharge or within 5 days postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of neurocognitive dysfunction at 90 days postoperatively | on the 90 days | assessed by AMTS scale |
| Degree of decline in activities of daily living at 90 days postoperatively | on the 90 days | use the IADL score |
| All-cause mortality | on the 90 days | — |
| Incidence of delayed cognitive recovery during hospitalization | Day 1 before surgery, day 5 after surgery, day 90 after surgery | The MMSE/MoCA scale were used for evaluation |
| 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 | At discharge or within 5 days postoperatively | 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 |
| Incidence of unplanned ICU or HDU admissions | on the 90 days | — |
Countries
China
Contacts
Primary ContactRuquan Han, MD
Outcome results
None listed