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

Not Applicable

• Conditions: Myocardial Injury

• Registration Number: NCT06759818
• Lead Sponsor: Affiliated Hospital of Jiaxing University

Brief 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.

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Study Start: 2025-01-01
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
high-sensitivity troponin T	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 Outcome Measures

Name	Time	Method
Myocardial injury after surgery	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
high-sensitivity troponin T	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.
NRS score 24 hours after surgery.	The three day after surgery	Evaluate patients' resting pain scores 24 hours after surgery.

Trial Locations

Locations (1)

The First Hospital of Jiaxing; 🇨🇳 Jiaxing, Zhejiang, China