The incidence of diabetes mellitus type II is increasing. More and more patients who need surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering protocols and the proven negative effects of hyperglycaemia. There is no evidence for the optimal glucose lowering protocol. This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.
Diabetes mellitus is associated with poor outcome after surgery. The prevalence of diabetes in hospitalised patients is up to 40%, meaning that the anaesthesiologist will encounter a diabetes patient in the operating room on a daily basis. Multiple protocols for perioperative glucose regulation have been developed, ranging from intravenous glucose-insulin-potassium infusion to subcutaneous bolus regimens. Despite this abundance of published glucose lowering protocols and the proven negative effects of intraoperative hyperglycaemia in diabetes, there is no evidence regarding the optimal intraoperative glucose lowering treatment. Recently, incretins have been introduced to lower blood glucose. The main hormone of the incretin system is glucagon-like peptide-1 (GLP-1). GLP-1 increases insulin and decreases glucagon secretion in a glucose-dependent manner, resulting in low incidence of hypoglycaemia. This study investigates for the first time the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus undergoing non-cardiac surgery. Objective: This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Academic Medical Center Amsterdam
Amsterdam, Please Select, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Median glucose
The difference in median glucose between the GIK + BR and LG group 1 hour after surgery
Time frame: 1 hour after surgery
Total Insulin administration
The difference in insulin administration between the GIK + BR and LG group within 24 h after start of surgery
Time frame: 1 day postoperative
Median glucose
The difference in median glucose between the GIK + BR and LG group 4 hours and 1 day after surgery
Time frame: 4 hours and 1 day postoperative
Postoperative complications
The difference in proportion of any postoperative complication within the first month
Time frame: 1 month after surgery
Hypoglycemia
The occurrence of mild and severe hypoglycemia (glucose \<4.0 mmol/l and \<2.3 mmol/l, respectively) during and up to 24 h after surgery
Time frame: From start treatment until the morning of day 1 postoperative
Hypo- and hyperkalemia
The occurrence of hypokalemia (\<3.5 mmol/l) and hyperkalemia (\>5.0 mmol/l) during and up to 24 h after surgery
Time frame: from start treatment until morning of day 1 postoperative
Glucose
the difference in median glucose 1hr preoperative, 1, 4 hours postoperative, 1 day postoperative between the three groups.
Time frame: From start treatment until morning of day 1 postoperative
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