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Transcutaneous Vagus Nerve Stimulation for the Prevention of Postoperative Delirium in Elderly Non-Cardiac Surgery Patients: A Multicenter, Randomized, Double-Blind, Controlled Study

Transcutaneous Vagus Nerve Stimulation for the Prevention of Postoperative Delirium in Elderly Non-Cardiac Surgery Patients: A Multicenter, Randomized, Double-Blind, Controlled Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090660
Enrollment
Unknown
Registered
2024-10-11
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

postoperative delirium

Interventions

Active stimulation group:The active stimulation group received active electrical stimulation to the left cymba conchae area of the ear. The stimulation frequency was 40 Hz, with a pulse width of 550 µ
Sham stimulation group:The sham stimulation group received electrical stimulation to the left earlobe area. The stimulation frequency was 40 Hz, with a pulse width of 550 µs, and a cycle of 50 seconds

Sponsors

the Second Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age = 65 years, < 85 years 2. Undergoing elective/urgent non-cardiac surgery,the expected surgery duration is =1 hour, and the hospital stay is =3 days. 3. ASA: I~III 4.Clear consciousness, able to communicate normally 5.Informed about and willing to participate in this study

Exclusion criteria

Exclusion criteria: 1. Diagnosed with delirium before surgery, or a history of confirmed neurological or psychiatric disorders; 2. Severe liver, kidney, heart, or lung dysfunction; 3.History of severe trauma or major surgery within the past year; 4. History of drug dependence or alcohol abuse; recent use of cholinergic, anticholinergic drugs, or steroids; 5. Local skin rash, infection, lesions, ulcers, or scars at the stimulation site; 6. History of implanted stimulators, cochlear implants, or metal implants in the body (excluding dental implants); 7. History of unilateral or bilateral vagus nerve injury; 8. Heart rate < 60 beats per minute; 9. Participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium(POD) incidence;

Secondary

MeasureTime frame
Severity of POD; Postoperative sleep quality;Pain; TNF-a level in peripheral blood;IL-6;IL-1ß;

Countries

China

Contacts

Public ContactJi Muhuo

The Second Affiliated Hospital of Nanjing Medical University

jimuhuo2019@126.com+86 159 9623 5006

Outcome results

None listed

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