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Effects of transcutaneous auricular vagus nerve stimulation on postoperative delirium induced by tourniquet application in elderly patients undergoing lower extremity surgery

Effects of transcutaneous auricular vagus nerve stimulation on postoperative delirium induced by tourniquet application in elderly patients undergoing lower extremity surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125066
Enrollment
Unknown
Registered
2026-05-20
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

postoperative delirium

Interventions

taVNS intervention group: The observation group used the vagus nerve stimulator and the disposable stimulation electrode was attached to the distribution area of the auricular branch of the vagus ner
the stimulation parameters were: continuous wave, frequency 20 Hz, pulse width 200 µs, initial current intensity 2 mA, adjusted gradually to 5~8 mA and maintained with the standard of "the patient fee
2.The operation day: the intervention was started 30 minutes before anesthesia induction and continued until 30 minutes after tourniquet deflation after the end of surgery, and the intraoperative stim
3.The first day after surgery: a single intervention was performed in the ward for 30 min with the same current intensity as the first day before surgery.
Control group:The control group wore the same stimulation electrodes and equipment as the observation group, with the same electrode placement position and intervention duration as the observation gro
after the patient reported feeling slight tingling and numbness, the device current output was turned off immediately, without effective electrical stimulation throughout the process, and only the dev

Sponsors

Xuzhou Central Hospital, Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years, any gender; 2. Scheduled for lower limb orthopedic surgery, with planned use of a tourniquet during surgery; 3. American Society of Anesthesiologists (ASA) classification I–III; 4. Basic normal cognitive function before surgery, MoCA score >= 26, MMSE score >= 24; 5. Patient or their legal representative is fully informed and has signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Preoperative presence of delirium, dementia (MoCA 1.5 or PLT 177 µmol/L), malignant tumors, or systemic active infections.

Design outcomes

Primary

MeasureTime frame
Occurrence of postoperative delirium (POD);Perioperative and rehabilitation indicators;

Secondary

MeasureTime frame
Cognitive function;Serological indicators;

Countries

China

Contacts

Public ContactWang Shuang

Xuzhou Central Hospital, Southeast University

925273503@qq.com+86 153 6588 8710

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026