Skip to main content
OpenTrials
Completed

NCT Number: NCT05136157

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ain-Shams University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Rapid-Acting Insulin

Drug

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

Other names: Crystalline insulin

Primary outcomes

  1. intra-operative CBG level between 140- 180 mg/dl all over the operation

    Time frame: 7 months

    Base line CBG will be measured for all patients then every 30 minutes and in the PACU

Secondary outcomes

  1. Total IU of rapidly acting insulin given to the patient

    Time frame: 7 months

    total units of insulin given to the patient will be calculated in the PACU

  2. Peri-operative changes in serum potassium

    Time frame: 7 months

    Base line serum potassium will be compared to that measured in the PACU

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 29, 2021
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.