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Enrolling by invitation NCT06759818

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Myocardial Injury in Elderly Patients Undergoing Thoracoscopic Surgery: a Prospective, Randomized Controlled Study

No phase Interventional Myocardial Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcutaneous vagus nerve stimulation, Sham stimulation group.
Who it may be relevant to
Registry conditions: Myocardial Injury. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This research group plans to design a prospective, double-blind, randomized controlled study to explore the effect of taVNS on hs-cTnT in elderly patients undergoing thoracoscopic surgery, and to evaluate the effect on perioperative myocardial injury and postoperative analgesia during thoracoscopic surgery.

Detailed description

A small number of studies based on transcutaneous auricular vagus nerve stimulation have shown that it has good therapeutic effects on patients with cardiovascular disease, and is simple to operate, with few complications and low risks. However, thoracic surgery is closer to the heart and has a higher incidence of perioperative myocardial injury. , and hs-cTnT has become a biomarker that predicts myocardial injury. This research group plans to design a prospective, double-blind, randomized controlled study to explore the effect of taVNS on hs-cTnT in elderly patients undergoing thoracoscopic surgery, and to evaluate the effect on perioperative myocardial injury and postoperative analgesia during thoracoscopic surgery.

Interventions

  • Device transcutaneous vagus nerve stimulation
    ①The first adjustment requires electrical stimulation to break through the skin barrier. The first intervention is the day before the operation. The initial electrical stimulation frequency is 30Hz and the pulse width is 300μs. The frequency and pulse width are adjusted according to the individual feelings of the subject until they are tolerated by the subject. Maximum current stimulation without discomfort and lasting for 30 minutes; ② second time For the intervention, the subject is connected
  • Device Sham stimulation group
    ① The first intervention is also the day before the operation. The frequency and pulse width are adjusted three times without turning on the machine, and the subject is asked if they have any feelings. After adjusting the frequency three times, no operation is performed for 30 minutes; ② The second intervention For the first intervention, after the monitor is connected in the operating room, the frequency and pulse width are not set, and it lasts for 30 minutes before being taken out; ③ For the

Primary outcome measures

  • high-sensitivity troponin T [Time frame: The first day after surgery]
Secondary outcome measures (3)
  • Myocardial injury after surgery [Time frame: 30 days after surgery]
  • high-sensitivity troponin T [Time frame: the third day after surgery]
  • NRS score 24 hours after surgery. [Time frame: The three day after surgery]

Eligibility criteria

Inclusion criteria

  • Aged ≥60 years old
  • Inpatients scheduled to undergo elective thoracoscopic lobectomy, segmentectomy, or wedge resection
  • ASA score of Ⅰ-Ⅲ
  • Able to communicate with the researcher Communicate and cooperate with patients completing assessment scales.

Exclusion criteria

  • Patients with congenital heart disease, coronary heart disease, myocardial infarction, severe heart block or implanted cardiac pacemaker
  • Patients with neurological diseases such as cerebral infarction, cerebral hemorrhage or stroke
  • Patients with pain, damage, infection or unhealed ear trauma in the area near the external auricle
  • Patients with a history of severe mental illness, abuse of analgesia or addiction to psychiatric drugs
  • Patients with severe digestive system diseases
  • Patients and their families who refuse surgical anesthesia or are unable to cooperate in completing the questionnaire
  • Pregnant women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of Jiaxing — Jiaxing

Publications

  • Ackland GL, Abbott TEF, Jones TF, Leuwer M, Pearse RM; VISION-UK Investigators; University College Hospital; Royal Liverpool University Hospital; Leeds Teaching Hospitals. Early elevation in plasma high-sensitivity troponin T and morbidity after elective noncardiac surgery: prospective multicentre observational cohort study. Br J Anaesth. 2020 May;124(5):535-543. doi: 10.1016/j.bja.2020.02.003. Ep PMID 32147104

Identifiers

NCT: NCT06759818 · 2024-LY-747

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗