Effects of intravenous and inhalation anesthesia on blood glucose and complications in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial

BACKGROUND: Diabetes mellitus (DM) is a metabolic disorder syndrome caused by relative or absolute lack of insulin and varying degrees of insulin resistance. The type and regimen of anesthesia may affect perioperative hyperglycemia following major surgical stress. The effect of perioperative anesthetics on the blood glucose level of diabetic patients will play an essential role in the postoperative recovery of patients. However, there is no rigorously-designed randomized controlled trial to compare the effects of total intravenous anesthesia (TIVA) and total inhalation anesthesia (TIHA) on blood glucose and complications in type 2 diabetes. Hence, we design this clinical trial to compare the effects of TIVA and TIHA of hyperglycemia and clinical outcomes in type 2 diabetes undergoing surgery. METHODS: This is a randomized, double-blind, parallel controlled trial. One hundred twelve patients with type 2 DM who meet the qualification criteria will be randomly divided into two groups: TIVA group and TIHA group. The levels of serum insulin and cortisol will be measured before and after the operation, and the levels of blood glucose at different setting time will be monitored. All patients will be followed up by blinded evaluators at baseline and 1, 3, 7, and 30 days after the intervention. The follow-up included postoperative complications [such as myocardial infarction (MI), stroke, renal failure, anastomotic fistula, stress ulcer, incision infection, lung infection] and adverse events. DISCUSSION: The routinely used clinical anesthesia schemes are TIVA, TIHA and intravenous-inhalation combined anesthesia. We expect that the results of this trial will provide high-quality clinical evidence for the choice of anesthesia options for patients with type 2 DM. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000029247, registration date: 20 January 2020.