Improvement of Postoperative Immunosuppression in Patients Receiving Coronary Artery Bypass Grafting by Transcutaneous Electrical Acupoint Stimulation: Study Protocol for a Double-blind Randomized Controlled Trial

Abstract Background: The coronary artery bypass grafting (CABG) is a surgery to relieve angina and reduce mortality of coronary heart disease. However, the patient is more prone to have immunosuppression after the surgery, causing secondary infection, and it is closely correlated to the occurrence and progress of tumor after surgery. More and more studies revealed that needle puncture was able to effectively regulate the function of immune system. However, its perioperative application is unclear. Therefore, this clinical study is aimed to evaluate whether the effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on improvement of immunosuppression of patients after receiving CABG. Methods: This clinical study was a single-center clinical trial. The 88 patients scheduled to receive CABG under extracorporeal circulation were randomized into 2 groups: the group of TEAS combined with general anesthesia (TEAS+GA), and the group of transcutaneous acupoint pseudo - electric stimulation combined with general anesthesia (Sham TEAS+GA). Human leukocyte antigen of monocyte (mHLA-DR) was the main endpoint to evaluate on the improvement of immunosuppression of patient after surgery. In addition, the monitoring indicators, such as interleukin-6 (IL-6), reactive protein C (CRP), high mobility group protein 1 (HMGB1), regulatory T cell (Treg) and secondary infection, etc., were recorded, and further statistical analysis was conducted. Discussion: This study performs TEAS intervention on patients scheduled to receive CABG under extracorporeal circulation in perioperative period, to improve their postoperative immunosuppression, reduce postoperative complications, reduce secondary infection rate, shorten hospital stay and improve the patient’s outcome. This study also aims to provide clinical evidence for application of this technique. However, TEAS related parameters in this study (stimulus intensity and waveform, intervention timing and duration, etc.) should be further optimized. Trial registration: This study was approved by Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine with the number 2016-455-06-01. The results of the trial will be published in an internationally peer-reviewed journal. This study was registered at ClinicalTrials with the Identifier NCT02933996 on 13 October 2016, https://www.clinicaltrials.gov/ct2/show/NCT02933996 Keywords: CABG; TEAS; immunosuppression; mHLA-DR