Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients
Vnstar-IIa
Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2024
CompletedFirst Posted
Study publicly available on registry
May 20, 2024
CompletedStudy Start
First participant enrolled
May 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 3, 2024
May 1, 2024
7 months
May 10, 2024
June 30, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
TaVNS tolerance
The proportion of subjects who completed all the expected interventions
1-5 days after surgery
Incidence of adverse events
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc
At discharge，an average of 2 weeks
Secondary Outcomes (5)
Incidence of POD at discharge or within 5 days postoperatively
At discharge or within 5 days postoperatively
Incidence of cognitive decline
Day 1 before surgery, day 5 after surgery, day 90 after surgery
All-cause mortality
on the 90 days
Postoperative pain
1-5 days after surgery
Time of anesthesia recovery
Within 2 hours after the end of the surgery
Study Arms (2)
Transauricular Vagal Nerve Stimulation
ACTIVE COMPARATORTransauricular Vagal Nerve sham Stimulation
SHAM COMPARATORInterventions
Transauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz
Eligibility Criteria
You may qualify if:
- Age≥65 years
- Expected operation time≥ 2 hours
- Postoperative hospital stay≥ 4 days
- Sign the informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 10, 2024
First Posted
May 20, 2024
Study Start
May 21, 2024
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
July 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share