Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vagus Nerve Stimulation
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- TaVNS tolerance
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Ruquan Han
professor
Beijing Tiantan Hospital
Eligibility 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
Outcomes
Primary Outcomes
TaVNS tolerance
Time Frame: 1-5 days after surgery
The proportion of subjects who completed all the expected interventions
Incidence of adverse events
Time Frame: At discharge，an average of 2 weeks
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc
Secondary Outcomes
- Postoperative pain(1-5 days after surgery)
- Incidence of POD at discharge or within 5 days postoperatively(At discharge or within 5 days postoperatively)
- All-cause mortality(on the 90 days)
- Incidence of cognitive decline(Day 1 before surgery, day 5 after surgery, day 90 after surgery)
- Time of anesthesia recovery(Within 2 hours after the end of the surgery)