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Clinical efficacy of continuous Tavns in preventing PND in frail patients: A Prospective Randomised Controlled Trial

Clinical study on the mechanism and efficacy of continuous tavns in preventing PND in debilitating patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118105
Enrollment
Unknown
Registered
2026-02-02
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Neurocognitive function

Interventions

Group T:The electric stimulator was placed in the bilateral ear nail boat area. Parameters: frequency 20Hz, pulse width 300 µ s, intensity limited to the patients tolerance (current intensity about 0.
Group C:Sham stimulation (the appearance of the device is the same, the electrode is attached to the non vagus nerve distribution area of the earlobe, and there is no current output)

Sponsors

Lishui People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: The age should be > = 65 years old and < = 90 years old (no limit for men and women); American Society of anesthesiologists (ASA) physical status class I-III; Elective surgery to be performed under general anesthesia; Preoperative frailty assessment met frail frailty assessment scale = 3 points; It can be treated with auricular acupoint electrical stimulation; Signed informed consent.

Exclusion criteria

Exclusion criteria: Severe hearing impairment or ear skin damage; Previous vagus nerve injury or pacemaker implantation; Preoperative Montreal Cognitive Assessment Scale (MoCA) < 27 points (education <= 12 years, plus 1 point); With severe mental disease or neurodegenerative disease (such as Alzheimer's disease).

Design outcomes

Primary

MeasureTime frame
the incidence of POD;

Secondary

MeasureTime frame
the incidence of DNR;the incidence of p-NCD;Inflammatory markers: serum tnf- a, IL-6, IL-1 ß were detected;Brain injury markers: detection of serum s100- ß, NSE;Postoperative recovery quality (qor-15);Vital signs (map, HR) at different time points;Adverse reactions during tavns treatment: dizziness and headache, local skin reaction, ear pain, nausea;Incidence of intraoperative adverse events: hypotension, bradycardia, hypertension, tachycardia;

Countries

China

Contacts

Public ContactDuan Gongchen

Lishui People's Hospital

981225178@qq.com+86 189 5709 3030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026