Clinical Trials in Degenerative Diseases

STUDY PROTOCOL
Year
: 2016  |  Volume : 1  |  Issue : 1  |  Page : 17--24

Transcutaneous electrical acupoint stimulation with different acupoint combinations on opioid consumption in patients undergoing off-pump coronary artery bypass grafting: study protocol for a randomized double-blind controlled trial


Hui Zhang1, Chong Lei1, Tao-yuan Zhang1, Li-hong Hou1, Qiang Wang1, Hai-long Dong1, Jian-ge Han2, Li-ze Xiong1 
1 Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shannxi Province, China
2 Department of Anesthesiology, Tianjin Chest Hospital, Tianjin, China

Correspondence Address:
Jian-ge Han
Department of Anesthesiology, Tianjin Chest Hospital, Tianjin
China
Li-ze Xiong
Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University, Xi«SQ»an, Shannxi Province
China

Background: The demand for improved anesthesia during off-pump coronary artery bypass grafting (OP-CABG) is continually increasing. Ensuring stable hemodynamics and balanced myocardial oxygen supply during OP-CABG are key issues that remain to be resolved. There is evidence that acupuncture anesthesia can decrease mortality after OP-CABG, while reducing the dose of anesthesia required, minimizing surgical complications, and decreasing medical costs. Acupuncture at distal-proximal acupoints in combination is the most commonly used method requiring acupoint compatibility. We hypothesize that electroacupuncture at distal-proximal and regional acupoints prior to OP-CABG will reduce the dosage of anesthesia required during OP-CABG, and minimize postoperative complications. Methods/Design: This prospective, randomized, double-blind, controlled trial will be performed at the Departments of Anesthesiology at Xijing Hospital, Fourth Military Medical University, and Tianjin Chest Hospital, China. A total of 186 patients scheduled for OP-CABG in these two hospitals will be included in the study. The patients will be divided into three groups: distal-proximal acupoints group (acupuncture at the Danzhong (CV17) and Hegu (LI4) acupoints); regional acupoints group (acupuncture at the Danzhong (CV17) and Juque (CV14) acupoints); and non-acupoint group (acupuncture at a site 2 cm lateral from the Danzhong (CV17) and Juque (CV14) acupoints). All interventions will start 30 minutes prior to anesthesia and continue until the beginning of anesthesia. The primary outcome is the dose of sufentanil used for anesthesia. Secondary outcomes are cardiac troponin I content, inotropic score, dose of propofol used for anesthesia, duration of mechanical ventilation, duration of stay in the intensive care unit, length of postoperative hospital stay, incidence of overall complications within 30 days of surgery, and incidence of overall mortality within 30 days of surgery. Adverse events will be also evaluated. Discussion: This trial protocol will determine whether acupuncture at distal-proximal or regional acupoints can reduce anesthetic dose and postoperative complications in OP-CABG surgery, with the purpose of ensuring patient safety in the perioperative phase. Trial registration: ClinicalTrals.gov identifier: NCT02443220; registered on 18 August 2014. Ethical approval: The protocol was approved by the Ethics Committee on Clinical Trials of Drugs, Xijing Hospital, and the Ethics Committee on Clinical Trials, Tianjin Chest Hospital, China. Written informed consent regarding trial procedure and treatment protocol will be obtained from each subject.


How to cite this article:
Zhang H, Lei C, Zhang Ty, Hou Lh, Wang Q, Dong Hl, Han Jg, Xiong Lz. Transcutaneous electrical acupoint stimulation with different acupoint combinations on opioid consumption in patients undergoing off-pump coronary artery bypass grafting: study protocol for a randomized double-blind controlled trial.Clin Trials Degener Dis 2016;1:17-24


How to cite this URL:
Zhang H, Lei C, Zhang Ty, Hou Lh, Wang Q, Dong Hl, Han Jg, Xiong Lz. Transcutaneous electrical acupoint stimulation with different acupoint combinations on opioid consumption in patients undergoing off-pump coronary artery bypass grafting: study protocol for a randomized double-blind controlled trial. Clin Trials Degener Dis [serial online] 2016 [cited 2021 May 6 ];1:17-24
Available from: https://www.clinicaltdd.com/article.asp?issn=2542-3975;year=2016;volume=1;issue=1;spage=17;epage=24;aulast=Zhang;type=0