Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control

Intraoperative Complications Clinical Trial

Official title:

Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control in Elective Laparotomy Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136157
• Other study ID #: R 16/2020/2021
• Status: Completed
• Phase: Early Phase 1
• Start date: November 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: October 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 15, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Intraoperative Complications

Intervention

Drug:
• Rapid-Acting Insulin
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

Locations

Country	Name	City	State
Egypt	Ain-Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra-operative CBG level between 140- 180 mg/dl all over the operation	Base line CBG will be measured for all patients then every 30 minutes and in the PACU	7 months
Secondary	Total IU of rapidly acting insulin given to the patient	total units of insulin given to the patient will be calculated in the PACU	7 months
Secondary	Peri-operative changes in serum potassium	Base line serum potassium will be compared to that measured in the PACU	7 months