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NCT Number: NCT06421077

Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location status: Recruiting

Location contact

Ruquan Han, M.D., Ph.D

CONTACT

[email protected]

8610-59976660

Ruquan Han, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transauricular auricular vagus nerve stimulation

Device

transauricular auricular vagus nerve stimulation

Primary outcomes

  1. Incidence of POD at discharge or within 5 days postoperatively

    Time frame: 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 outcomes

  1. Incidence of delayed cognitive recovery during hospitalization

    Time frame: Day 1 before surgery, day 5 after surgery, day 90 after surgery

    The MMSE/MoCA scale were used for evaluation

  2. Incidence of neurocognitive dysfunction at 90 days postoperatively

    Time frame: on the 90 days

    assessed by AMTS scale

  3. Degree of decline in activities of daily living at 90 days postoperatively

    Time frame: on the 90 days

    use the IADL score

  4. All-cause mortality

    Time frame: on the 90 days

  5. Incidence of unplanned ICU or HDU admissions

    Time frame: on the 90 days

  6. Proportion of patients requiring higher levels of care postdischarge, specifically long-term care.

    Time frame: on the 90 days

  7. Length of hospital stay

    Time frame: on the 90 days

  8. Delirium severity

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ruquan Han, MD

CONTACT

[email protected]

8610-59976660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Prevents Postoperative Delirium in Elderly Patients: a Randomized Controlled Study

Acronym: Vnstar

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 20, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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