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The Efficacy of "Transcutaneous Auricular Vagus Nerve Stimulation" for Preventing Postoperative Delirium in Elderly Patients After Major Surgery: A Multicenter, Double-blind, Randomized, Controlled Trial

The Efficacy of "Transcutaneous Auricular Vagus Nerve Stimulation" for Preventing Postoperative Delirium in Elderly Patients After Major Surgery: A Multicenter, Double-blind, Randomized, Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081078
Enrollment
Unknown
Registered
2024-02-21
Start date
2024-07-29
Completion date
Unknown
Last updated
2025-02-17

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 of the left cymba conchae, with a frequency of 30 Hz, pulse width of 250µs, on for 30 s/off for 30 s, conti
Sham stimulation group:The sham stimulation group received treatment of the same period, with sham stimulation applied through electrodes placed on the left cymba conchae, using the same method to adj

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: ? Age =65 years old. ? Undergoing elective major surgery under general anesthesia (including radical resection for liver/pancreas and gastric malignant tumors, hip replacement surgery, esophageal/cardiac/major vascular surgery, etc.). ? American Society of Anesthesiologists (ASA) physical status classification 1-3. ? Expected surgery time greater than 2 hours, expected hospital stay greater than 3 days. ? Can understand the research process and use of various assessment scales, and communicate effectively with researchers. ? The patient volunteers to participate in this study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: ? Presence of visual or hearing impairment. ? History of abuse of opioids or other drugs. ?Patients unable to undergo various assessments. ? Re-surgery within a short period (within 5 days). ? Vulnerable groups, including patients with mental illness, cognitive impairment, severe illness, minors, pregnant women, illiterates, etc.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium(POD) incidence;

Secondary

MeasureTime frame
Severity of POD;Postoperative recovery quality;Postoperative sleep quality;Creatinine;postoperative complications;

Countries

China

Contacts

Public ContactGang Chen

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

chengang120@hotmail.com+86 137 5711 8681

Outcome results

None listed

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