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Transcutaneous Electrical Stimulation of the Vagus Nerve

The Effect of Transcutaneous Electrical Stimulation of the Vagus Nerve on Reduction of Postoperative Cognitive Dysfunction in Elderly Patients After Hip or Knee Arthroplasty

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03989375
Acronym
TESVNR
Enrollment
110
Registered
2019-06-18
Start date
2019-07-01
Completion date
2025-07-01
Last updated
2019-06-18

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

Conditions

Cognitive Dysfunction

Keywords

postoperative Cognitive Dysfunction, hip- and knee arthroplasty, transcutaneous vagus nerve stimulation

Brief summary

This study evaluate the cognitive functions of patient after hip or kneel replacement.Half of the patient will receive transcutaneous vagus nerve electrical stimulation during the surgery while the other half will get placebo therapy

Interventions

DEVICEtranscutaneous vagus nerve electric stimulator

The stimulator that can be attached to ears of the patient.We suppose that this device can reduce the incidence of perioperative neurocognitive disorders(PND)

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* over 65 years old * ability to communication * hip or kneel replacement * willing to participate in the study * ASA I-II

Exclusion criteria

* with cerebral disorders or disease * cognitive impairment before surgery * with mental disease * unable to communication * severe eyes or ears impairment * surgery performed in the past 30 days * Bradycardia,II°AVB,III°AVB,severe heart, liver and kidney dysfunction * severe skin disease * refuse to enter the study

Design outcomes

Primary

MeasureTime frameDescription
Incidence of perioperative neurocognitive disordersone monthmake different scale before and after operation to evaluate neurocognitive changes in experiment group and control group.

Countries

China

Contacts

Primary ContactDiansan Su
diansansu@yahoo.com+862168383702
Backup ContactYichen Fan
mcking95@126.com+86 13482827569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026