Increase in blood glucose during surgey

Completed

• Conditions: Glycemic status during intraoperative period

• Registration Number: CTRI/2012/09/003021
• Lead Sponsor: Souvik Maitra

Brief Summary

*BACKGROUND*

*The study was undertaken to observe the effect of different maintenance fluid regimen on intraoperative blood glucose levels in nondiabetic patients undergoing elective major noncardiac surgery under general anaesthesia.*

*METHODS*

*Two hundred nondiabetic patients (100 in each group) aged between 18 and 60 yrs were enrolled for this prospective randomized parallel group study.*

*Group A patients received Ringer’s lactate solution and group B patients received 0.45% sodium chloride with 5% dextrose and 20 mmol/L potassium chloride as maintenance fluid. Capillary blood glucose (CBG) level was measured immediately before initiation of intravenous fluid therapy and there after hourly till the end of surgery.*

*If at any time intraoperative CBG was found to be more than or equal to 150 mg/dL calculated dose of human soluble insulin was given as intravenous bolus equal to the amount of CBG/100 units.*

*RESULTS*

63% patients in group B developed at least one episode of hyperglycemia (CBG ≥ 150 mg/dL) but only 29% in the group A did so.  Insulin consumption was significantly higher in group B than in group A to maintain normoglycemia**.** The relative risk of becoming hyperglycemic in group B patients is 2.172 (95% CI 1.544 to 3.057). Number needed to harm, i.e. hyperglycemia, in group B is 2.941 (95% CI 2 to 5).

CONCLUSION

We conclude that stress induced hyperglycemic response in patients undergoing major noncardiac surgery is common in nondiabetic population.  Maintenance fluid therapy by *dextrose containing solution* *as opposed to* *RL* *solution increases the incidence of hyperglycemia. To achieve normoglycemia by intravenous bolus dose of human regular insulin, significantly higher doses are required in patients* *receiving dextrose**containing saline* *as maintenance fluid.*

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-22
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Nondiabetic patients of ASA physical status I or II of age group 18-60 years of either sex undergoing major noncardiac surgery (duration > 2 hours) under general anaesthesia.

Exclusion Criteria

Unwilling patients Patients with diabetes mellitus, impaired postprandial glucose tolerance (2h postprandial blood glucose > 126 mg/dL) and impaired fasting glucose (fasting blood glucose > 106 mg/dL) Patients with severe respiratory, cardiovascular, neurological or renal disease ASA physical status III and IV Haemodynamically unstable patients Pregnancy Body weight < 35 kg Body weight > 75 kg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative hyperglycemia (Blood glucose 150 mg/dl)	Blood glucose was assessed initially just before iv cannulation and again at hourly interval till the end of surgery.

Secondary Outcome Measures

Name	Time	Method
Requirement of insulin to maintain normoglycemia	When we find a Blood glucose level is higher than 150 mg/dl during CBG monitoring, designated dose of Insulin was administered. Total requirement of Insulin was calculated

Trial Locations

Locations (1)

Main Operation Theatre, Main Block Second Floor; 🇮🇳 Kolkata, WEST BENGAL, India

Main Operation Theatre, Main Block Second Floor

🇮🇳Kolkata, WEST BENGAL, India

Souvik Maitra

Principal investigator

9968859756

souvikmaitra@live.com