The Effect Of Dexmedetomidine On The Perioperative Liver Function Of Diabetic Patients: Study Protocol For A Double-blinded 2 × 2 Factorial Randomized Controlled Trial.

Abstract

Abstract Introduction Type 2 diabetes mellitus (T2DM) is one of the high-risk factors for gallbladder stones, and laparoscopic cholecystectomy (LC) is currently the common treatment for this disease. Oxidative stress (OS) and inflammatory response induced by intraoperative pneumoperitoneum may cause damage to liver function in patients with T2DM. Dexmedetomidine has sedative, analgesic, and anti-sympathetic effects. Several studies have reported that dexmedetomidine is a highly selective α2-adrenergic receptor agonist that protects liver function in perioperative patients by inhibiting OS and inflammatory response. However, patients with T2DM have not been included in the previous studies. The purpose of this study is to investigate the effects of perioperative low-dose dexmedetomidine on perioperative liver function in T2DM patients. Methods and analysisThis is a double-blinded, randomized controlled trial using a 2×2 factorial trial design, which will be conducted from April 2022 to April 2024. Seventy-six patients undergoing elective LC will be included in this study, 38 with T2DM and 38 without diabetes, and they will be randomized into four groups (n=19 per group): nondiabetic dexmedetomidine group (ND group) and diabetic dexmedetomidine group (DD group) (intravenous pump injection with 4µg/ml dexmedetomidine) and nondiabetic control group (NC group) and diabetic control group (DC group) (intravenous pump injection with the same dose of normal saline). The main result is the activity of liver enzymes (AST, ALT, GGT). Secondary results include biomarkers of oxidative stress (ROS, MDA, SOD) and inflammatory response (TNF-α, IL-6). Ethics and disseminationThis study was approved by the Ethics Committee of The First Affiliated Hospital of Chengdu Medical College (2020CYFYHEC-BA-64). The results of the trial will be presented at national and international meetings relevant to the topic area and submitted to international peer-reviewed journals. Trial registration numberChiCTR2100049440. Registered April 9, 2022 https://www.chictr.org.cn/showproj.html?proj=131021