Intraoperative Complications
Conditions
Keywords
Insulin, Intra operative, Sliding scale, Bolus- infusion
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
Interventions
50 IU of rapid acting insulin taken by a 100 units (1ml) insulin syringe will be added to a 50 ml syringe containing normal saline (NS) to have a total volume of 50 ml with a concentration of 1 IU of insulin per 1 ml of NS
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intra-operative CBG level between 140- 180 mg/dl all over the operation | 7 months | Base line CBG will be measured for all patients then every 30 minutes and in the PACU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total IU of rapidly acting insulin given to the patient | 7 months | total units of insulin given to the patient will be calculated in the PACU |
| Peri-operative changes in serum potassium | 7 months | Base line serum potassium will be compared to that measured in the PACU |
Countries
Egypt
Outcome results
None listed