Comparison of dexmedetomidine and meperidine for the prevention of shivering following coronary artery bypass graft: study protocol of a randomised controlled trial

Abstract

Introduction: Shivering is a common complication in the postoperative period. The incidence of shivering has been reported to range from 5% to 65% under general anaesthesia and as 33% during epidural anaesthesia. Shivering can increase perioperative risk in patients. Both dexmedetomidine and meperidine are effective agents for the prevention of postanaesthetic shivering. However, few studies have compared the anti-shivering effects of different agents following coronary artery bypass graft (CABG). This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.

Methods and analysis: A total of 180 patients aged 18-75 years, with an American Society of Anesthesiologists (ASA) grade of II-IV, undergoing elective CABG will be enrolled and randomly assigned to the dexmedetomidine, meperidine and control groups (placebo) in an intended 1:1:1 allocation ratio. The patients will be followed up for 7 days after surgery. The primary outcome is the incidence of shivering within 24 hours postoperatively. The secondary outcomes are the number of remedial drugs used after surgery, the incidence of postoperative hypotension and bradycardia, sedation scores, endotracheal extubation time, intensive care unit length of stay, incidence of postoperative delirium within 7 days after surgery, incidence of postoperative arrhythmias, incidence of postoperative nausea and vomiting, average hospital length of stay and mortality rate 30 days after surgery.

Ethics and dissemination: The study protocol was approved by the ethics committee of The First Affiliated Hospital of Shandong First Medical University on 20 January 2021 (YXLL-KY-2021(002)) and registered at ClinicalTrials.gov. The results of this study will be presented at national and international scientific meetings and conferences. We plan to publish the data in peer-reviewed international scientific journals.

Trial registration number: NCT04735965.

Keywords: adult intensive & critical care; anaesthesia in cardiology; cardiac surgery; coronary heart disease.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Consolidated standards of reporting trials flow diagram. ICU, intensive care unit; PONV, postoperative nausea and vomiting.

Figure 2

Standard Protocol Items: Recommendations for Interventional Trials. -t1, the day before surgery; 0, day of surgery; t1, 30 min before the end of surgery; t2, 15 min after study drug administration; t3, within postoperative 24 hours; t4, within postoperative 3 days; t5, within postoperative 7 days; t6, within postoperative 30 days. ICU, intensive care unit; PONV, postoperative nausea and vomiting.