Clinical trial NCT06759818: Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Myocardial Injury in Elderly Patients Undergoing Thoracoscopic Surgery: a Prospective, Randomized Controlled Study
Official title: Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Myocardial Injury in Elderly Patients Undergoing Thoracoscopic Surgery: a Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myocardial Injury
Keywords: taVNS
myocardial injury
hs-cTnT
thoracoscopic surgery
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: high-sensitivity troponin T
timeFrame: The first day after surgery
Secondary outcomes:
measure: Myocardial injury after surgery
timeFrame: 30 days after surgery
measure: high-sensitivity troponin T
timeFrame: the third day after surgery
measure: NRS score 24 hours after surgery.
timeFrame: The three day after surgery
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
Study officials:
affiliation: Jiaxing University Affiliated Hospital
name: Qinghe Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiaxing University Affiliated Hospital.
name: Mingzi An, MD
role: STUDY_DIRECTOR
References:
citation: 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.