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

NCT06759818 | Enrolling By Invitation DMC

• 1 other identifier: 2024-LY-747
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Injury

Keywords

taVNS; myocardial injury; hs-cTnT; thoracoscopic surgery

Outcome Measures

Primary Outcomes (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.

  The first day after surgery

Secondary Outcomes (3)

• Myocardial injury after surgery

  30 days after surgery

• high-sensitivity troponin T

  the third day after surgery

• NRS score 24 hours after surgery.

  The three day after surgery

Study Arms (2)

transcutaneous vagus nerve stimulation

EXPERIMENTAL

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.

Device: transcutaneous vagus nerve stimulation

Sham stimulation group

PLACEBO COMPARATOR

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.

Device: Sham stimulation group

Interventions

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.

transcutaneous vagus nerve stimulation

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.

Sham stimulation group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China

Location

Related Publications (1)

• 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.

  PMID: 32147104 BACKGROUND

Study Officials

• Qinghe Zhou

  Jiaxing University Affiliated Hospital

  PRINCIPAL INVESTIGATOR

• Mingzi An, MD

  Jiaxing University Affiliated Hospital.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Hospital of Jiaxing University

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)