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Myocardial InjuryNCT06759818

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

A study testing transcutaneous vagus nerve stimulation in people with Myocardial Injury, run by Affiliated Hospital of Jiaxing University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Myocardial Injury
What is being tested?
transcutaneous vagus nerve stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
1 siteChina
Study dates
1 Jan 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314000

Other trials in China

About this study

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.

Read the 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.

Being tested
transcutaneous vagus nerve stimulation, Sham stimulation group
Keywords
taVNS, myocardial injury, hs-cTnT, thoracoscopic surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcutaneous vagus nerve stimulationDevice

    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 to the monitor after entering the surgery room. After observing that the subject\'s vital signs are within the normal range, the same stimulation frequency as the first time is immediately given for 30 minutes; ③ The third intervention is after the subject\'s surgery is completed. The same stimulation frequency was given in the resuscitation room until the patient was extubated and resuscitated.

  • Sham stimulation groupDevice

    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 third intervention, after the subject\'s surgery, earplugs are inserted in the recovery room, and the frequency and pulse width are not set. Remove the earplugs after extubation resuscitation is completed.

Study groups in NCT06759818
Study groupRoleWhat they receive
transcutaneous vagus nerve stimulationExperimental①The 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 to the monitor after entering the surgery room. After observing that the subject\'s vital signs are within the normal range, the same stimulation frequency as the first time is immediately given for 30 minutes; ③ The third intervention is after the subject\'s surgery is completed. The same stimulation frequency was given in the resuscitation room until the patient was extubated and resuscitated.
Receives: Device: transcutaneous vagus nerve stimulation
Sham stimulation groupPlacebo comparator① 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 third intervention, after the subject\'s surgery, earplugs are inserted in the recovery room, and the frequency and pulse width are not set. Remove the earplugs after extubation resuscitation is completed.
Receives: Device: Sham stimulation group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. high-sensitivity troponin T

    Trained researchers will draw 3-5ml blood samples before surgery, on the first day after surgery, and on the third day after surgery and store them in vacuum blood collection tubes containing lithium heparin. They will be temporarily stored in a refrigerator at 2-8°C within 24 hours. Sent to laboratory for analysis. All blood samples were analyzed by staff who received professional training in detecting Hs-cTnT using the Roche cobas e411 electrochemiluminescence fully automatic immunoassay analyzer.

    Measured: The first day after surgery

Secondary outcomes (3)

  1. Myocardial injury after surgery

    The 30-day MINS follow-up after surgery includes whether the patient has symptoms of myocardial ischemia such as chest tightness, angina pectoris, myocardial infarction, etc. It is also recommended that the patient come to the hospital for review of electrocardiogram and hs-cTnT and other indicators. Combining the current manufacturer-defined abnormal thresholds and the latest MINS study recommendations, we define MINS diagnostic criteria as hs-cTnT levels exceeding 14 ng/L during noncardiac surgery or within 30 days after surgery, and are at least 1 higher than the preoperative hs-cTnT level

    Measured: 30 days after surgery

  2. high-sensitivity troponin T

    Trained researchers will draw 3-5ml blood samples before surgery, on the first day after surgery, and on the third day after surgery and store them in vacuum blood collection tubes containing lithium heparin. They will be temporarily stored in a refrigerator at 2-8°C within 24 hours. Sent to laboratory for analysis. All blood samples were analyzed by staff who received professional training in detecting Hs-cTnT using the Roche cobas e411 electrochemiluminescence fully automatic immunoassay analyzer.

    Measured: the third day after surgery

  3. NRS score 24 hours after surgery.

    Evaluate patients' resting pain scores 24 hours after surgery.

    Measured: The three day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start1 Jan 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06759818
Sponsor's protocol ID
2024-LY-747
Status last verified
Dec 2024
First submitted
29 Dec 2024
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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. Epub 2020 Mar 5.

    PubMed 32147104

Questions about this trial

What is this clinical trial studying?

A study testing transcutaneous vagus nerve stimulation in people with Myocardial Injury, run by Affiliated Hospital of Jiaxing University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

high-sensitivity troponin T (time frame: The first day after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06759818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.

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