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

Primary Purpose

Intraoperative Complications

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Rapid-Acting Insulin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Complications focused on measuring Insulin, Intra operative, Sliding scale, Bolus- infusion

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • Ain-Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study group

Control group

Arm Description

Bolus-Infusion approach of rapidly acting crystalline insulin. The patient intra-operative blood glucose will be divided by 100. The resultant rapidly acting crystalline insulin units will be given intravenously over 10 minutes, and then continued as an intra-venous infusion per hour. The Capillary Blood Glucose (CBG) will be measured every 30 minutes and in the PACU with readjustment of the bolus-infusion dose as required

The sliding scale approach of rapidly acting crystalline insulin will be used according to the intra-operative blood glucose; 4 IU of insulin will be given when the CBG 180-250 mg/dl, 6 IU of insulin will be given when the CBG 251-300 mg/dl, 8 IU of insulin will be given when the CBG 301-350 mg/dl and 10 IU of insulin will be given when the CBG 351-400 mg/dl (5). The CBG will be measured every 30 minutes and in the PACU.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total IU of rapidly acting insulin given to the patient
total units of insulin given to the patient will be calculated in the PACU
Peri-operative changes in serum potassium
Base line serum potassium will be compared to that measured in the PACU

Full Information

First Posted
October 8, 2021
Last Updated
October 24, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05136157
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Complications
Keywords
Insulin, Intra operative, Sliding scale, Bolus- infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Bolus-Infusion approach of rapidly acting crystalline insulin. The patient intra-operative blood glucose will be divided by 100. The resultant rapidly acting crystalline insulin units will be given intravenously over 10 minutes, and then continued as an intra-venous infusion per hour. The Capillary Blood Glucose (CBG) will be measured every 30 minutes and in the PACU with readjustment of the bolus-infusion dose as required
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The sliding scale approach of rapidly acting crystalline insulin will be used according to the intra-operative blood glucose; 4 IU of insulin will be given when the CBG 180-250 mg/dl, 6 IU of insulin will be given when the CBG 251-300 mg/dl, 8 IU of insulin will be given when the CBG 301-350 mg/dl and 10 IU of insulin will be given when the CBG 351-400 mg/dl (5). The CBG will be measured every 30 minutes and in the PACU.
Intervention Type
Drug
Intervention Name(s)
Rapid-Acting Insulin
Other Intervention Name(s)
Crystalline insulin
Intervention Description
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
Primary Outcome Measure Information:
Title
intra-operative CBG level between 140- 180 mg/dl all over the operation
Description
Base line CBG will be measured for all patients then every 30 minutes and in the PACU
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Total IU of rapidly acting insulin given to the patient
Description
total units of insulin given to the patient will be calculated in the PACU
Time Frame
7 months
Title
Peri-operative changes in serum potassium
Description
Base line serum potassium will be compared to that measured in the PACU
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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%.
Facility Information:
Facility Name
Ain-Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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