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CTRI Number  CTRI/2012/09/003021 [Registered on: 26/09/2012] Trial Registered Retrospectively
Last Modified On: 05/06/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Increase in blood glucose during surgey 
Scientific Title of Study   Intraoperative blood glucose levels in nondiabetic patients undergoing elective major surgery under general anaesthesia receiving crystalloid solutions for maintenance fluid 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Souvik Maitra 
Designation  Post Graduate Resident 
Affiliation  IPGME&R, SSKM Hospital, Kolkata 
Address  162 MM Ghosh Road, Dumdum Kolkata
242 AJC Bose Road, Kolkata- 700020 WB
Kolkata
WEST BENGAL
700074
India 
Phone    
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Samarendra Pal 
Designation  Professorr 
Affiliation   
Address  Department of Anaesthesiology, Main Block, 2nd Floor, IPGME&R and SSKM Hospital, 244 AJC Bose Road

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  palsamarendra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Souvik Maitra 
Designation  Post Graduate Resident 
Affiliation  IPGME&R, SSKM Hospital, Kolkata 
Address  162 MM Ghosh Road, Dumdum Kolkata

Kolkata
WEST BENGAL
700074
India 
Phone    
Fax    
Email  souvikmaitra@live.com  
 
Source of Monetary or Material Support  
Personal funding: The expenses of glucometer and glucose-sticks were bought by the principal investigator.  
 
Primary Sponsor  
Name  Souvik Maitra 
Address  Flat A1, 162 MM Ghosh Road Dumdum,Kolkata- 74 
Type of Sponsor  Other [Personal funding] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Souvik Maitra  Main Operation Theatre, Main Block Second Floor  IPGMER & SSKM Hospital 244 AJC Bose Road, Kolkata- 20
Kolkata
WEST BENGAL 
9968859756

souvikmaitra@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, IPGMER, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Glycemic status during intraoperative period,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  5% Dextrose  Patients in Gr B received 5% dextrose- 0.45% NaCl with 10 meq/l KCl as maintenance fluid. Fluid infusion rate will be according to the "4-2-1" rule and duration is throughout the surgery. 
Comparator Agent  Ringer lactate  Patients in Gr A received RL as maintenance fluid. Fluid infusion rate will be according to the "4-2-1" rule and duration is throughout the surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  ï‚§ Unwilling patients
ï‚§ 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)
ï‚§ Patients with severe respiratory, cardiovascular, neurological or renal disease
ï‚§ ASA physical status III and IV
ï‚§ Haemodynamically unstable patients
ï‚§ Pregnancy
ï‚§ Body weight < 35 kg
ï‚§ Body weight > 75 kg
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/01/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 
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