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Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Postoperative Delirium in Elderly Patients Undergoing Lower Major Joint Replacement: A Randomized Controlled Trial

Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Postoperative Delirium in Elderly Patients Undergoing Lower Major Joint Replacement: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001153
Enrollment
Unknown
Registered
2025-06-12
Start date
2025-06-25
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative delirium

Interventions

taVNS group:The patients tragus was stimulated using transcutaneous auricular vagus nerve
sham stimulation group:The patients earlobe was stimulated using transcutaneous auricular vagus nerve

Sponsors

People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 65-80 years 2. American Society of Anesthesiologists (ASA) physical status II–III 3. Scheduled for elective unilateral total knee arthroplasty under general anesthesia 4. Able to provide written informed consent 5. Sufficient comprehension of Mandarin Chinese to follow study instructions

Exclusion criteria

Exclusion criteria: 1. Baseline dementia diagnosed using DSM-5 criteria 2. Montreal Cognitive Assessment score <19 3. Implanted electrical devices (e.g. pacemakers deep brain stimulators) 4. Active infection at the auricular acupuncture sites 5. Severe hematological or hemorrhagic disease 6. Severe sensory impairments preventing reliable cognitive assessment 7. Current alcohol or illicit drug use disorder 8. Current use of sedatives antidepressants or glucocorticoids 9. Receipt of acupuncture or electroacupuncture within one month before surgery 10. Any condition deemed unsafe for trial participation by the research team

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative delirium within 72 hours after surgery;

Secondary

MeasureTime frame
Postoperative pain score;Cognitive function;Sleep quality;Recovery quality;Cerebral perfusion;Hospital length of stay;Delirium subtype;Inflammatory markers;Autonomic function;Psychological status;The incidence of major postoperative complications;Delirium severity;30-day readmission rates;

Countries

China

Contacts

Public ContactLei Chen

People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

492014525@qq.com15980287770

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026