Clinical trial NCT05136157: Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control
Official title: Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control in Elective Laparotomy Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Intraoperative Complications
Keywords: Insulin
Intra operative
Sliding scale
Bolus- infusion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pre-operative blood glucose (BG) concentrations in type 2 diabetic patients undergoing elective non-cardiac surgery; have an increased incidence of in-hospital morbidity for cardiopulmonary and infectious complications. Also, hyperglycemia is associated with increased production and impaired scavenging of oxygen reactive species, polymorph nuclear neutrophil dysfunction and decreased intracellular killing, resulting in poor wound healing and increased risk of infection. Thus, perioperative optimal glucose management contributes to reduced morbidity and mortality. Recommendations favor moderate levels of capillary blood glucose (CBG); maintaining it in the range of 140-180 mg/dl.

Peri-operative doses of rapidly acting insulin for glycemic control could be done by the sliding scale or the bolus-infusion approaches. The sliding scale of insulin is commonly used to manage peri-operative hyper-glycaemia. It involves administering prescribed doses of insulin when the CBG is within determined ranges and withholding insulin when the CBG is within normal range. When used as a sole therapy; it results in under-insulinisation and thus hyper-glycaemia. The use of a dynamic insulin regimen like the intravenous bolus-infusion approach; allows adjusting the blood glucose level according to the insulin sensitivity of each patient, thus, better glucose control and less variations than the intermittent intravenous bolus of short-acting insulin in the sliding scale despite the same blood glucose target.

Detailed description: compare the rapidly acting insulin injection via the bolus-infusion approach (Study group) to the sliding scale approach (Control group) as regards the intra-operative glycemic control

Eligibility criteria: Inclusion Criteria:

* ASA physical status II patients
* aged 21-65 years
* known to have type1 or 2 diabetes mellitusw
* pre-operative fasting blood glucose level ˂ 350 mg/dl
* scheduled to undergo elective laparotomy surgeries
* expected to exceed 2 hours duration under general anesthesia

Exclusion Criteria:

* Patients' refusal
* diabetic ketoacidosis
* hyperglycemic hyperosmolar syndrome
* serum potassium ˂3.5 mEq/L
* HbA1c \>8.5%.

Primary outcomes:
measure: intra-operative CBG level between 140- 180 mg/dl all over the operation
timeFrame: 7 months
Secondary outcomes:
measure: Total IU of rapidly acting insulin given to the patient
timeFrame: 7 months
measure: Peri-operative changes in serum potassium
timeFrame: 7 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University
Study officials:
References: