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

Affiliated Hospital of Jiaxing University

Status: Invitation-only

Conditions: Myocardial Injury

Treatments: Device: Sham stimulation group; Device: transcutaneous vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06759818

2024-LY-747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

126 participants in 2 patient groups, including a placebo group

transcutaneous vagus nerve stimulation

Experimental group

Description:

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.

Treatment:

Device: transcutaneous vagus nerve stimulation

Sham stimulation group

Placebo Comparator group

Description:

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.

Treatment:

Device: Sham stimulation group