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Enrolling by Invitation

NCT Number: NCT06759818

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

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Key information

Conditions

Myocardial Injury

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous vagus nerve stimulation

Device

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 group

Device

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.

Primary outcomes

  1. high-sensitivity troponin T

    Time frame: The first day after surgery

    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.

Secondary outcomes

  1. Myocardial injury after surgery

    Time frame: 30 days 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

  2. high-sensitivity troponin T

    Time frame: the third day after surgery

    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.

  3. NRS score 24 hours after surgery.

    Time frame: The three day after surgery

    Evaluate patients' resting pain scores 24 hours after surgery.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiaxing University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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