Clinical trial NCT06421077: Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients
Official title: Transcutaneous Auricular Vagus Nerve Stimulation （taVNS）Prevents Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vagus Nerve Stimulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 1776
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of POD at discharge or within 5 days postoperatively
timeFrame: At discharge or within 5 days postoperatively
Secondary outcomes:
measure: Incidence of delayed cognitive recovery during hospitalization
timeFrame: Day 1 before surgery, day 5 after surgery, day 90 after surgery
measure: Incidence of neurocognitive dysfunction at 90 days postoperatively
timeFrame: on the 90 days
measure: Degree of decline in activities of daily living at 90 days postoperatively
timeFrame: on the 90 days
measure: All-cause mortality
timeFrame: on the 90 days
measure: Incidence of unplanned ICU or HDU admissions
timeFrame: on the 90 days
measure: Proportion of patients requiring higher levels of care postdischarge, specifically long-term care.
timeFrame: on the 90 days
measure: Length of hospital stay
timeFrame: on the 90 days
measure: Delirium severity
timeFrame: At discharge or within 5 days postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
References: