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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05136157

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Complications	Drug: Rapid-Acting Insulin	Early Phase 1

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study group 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	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 Other Names: Crystalline insulin
Active Comparator: Control group 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.	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 Other Names: Crystalline insulin

Arm

Intervention/Treatment

Active Comparator: Study group

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

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

Other Names:

Crystalline insulin

Active Comparator: Control group

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.

Drug: Rapid-Acting Insulin

Other Names:

Crystalline insulin

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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%.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain-Shams University	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ghada M.Samir, Assistant Professor of Anesthesia, Intensive care and Pain Management, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05136157

Other Study ID Numbers:

R 16/2020/2021

First Posted:

Nov 29, 2021

Last Update Posted:

May 10, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Ghada M.Samir, Assistant Professor of Anesthesia, Intensive care and Pain Management, Ain Shams University

Additional relevant MeSH terms:

Intraoperative Complications

Insulin

Insulin, Globin Zinc

Insulin, Short-Acting

Study Results

No Results Posted as of May 10, 2022