Vagus Nerve Stimulation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Transauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz
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 |
|---|---|---|
| TaVNS tolerance | 1-5 days after surgery | The proportion of subjects who completed all the expected interventions |
| Incidence of adverse events | At discharge，an average of 2 weeks | Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | on the 90 days | — |
| 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. |
| Time of anesthesia recovery | Within 2 hours after the end of the surgery | — |
| Postoperative pain | 1-5 days after surgery | VAS score |
| Incidence of cognitive decline | Day 1 before surgery, day 5 after surgery, day 90 after surgery | The MMSE scale and MoCA scale was used for evaluation |
Countries
China
Contacts
Primary ContactRuquan Han, MD
Outcome results
None listed