Transcutaneous Auricular Vagus Nerve Stimulation Prevents Postoperative Delirium in Elderly Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥65 years

Expected operation time≥ 2 hours

Postoperative hospital stay≥ 4 days

Sign the informed consent form

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • transauricular auricular vagus nerve stimulation

    Device

    transauricular auricular vagus nerve stimulation

Treatment groups

1,776 Participants
are divided into 2 treatment groups
Group A: taVNS with "standard-stimulation parameters"Active comparator 1 intervention
Group B: taVNS with "low-stimulation parameters"Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of POD 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 frame
At discharge or within 5 days postoperatively

Secondary outcomes

1

Incidence of delayed cognitive recovery during hospitalization

The MMSE/MoCA scale were used for evaluation

Time frame
Day 1 before surgery, day 5 after surgery, day 90 after surgery
2

Incidence of neurocognitive dysfunction at 90 days postoperatively

assessed by AMTS scale

Time frame
on the 90 days
3

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

use the IADL score

Time frame
on the 90 days
4

All-cause mortality

Time frame
on the 90 days

Other outcomes

Sponsors and contacts

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