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CTRI Number  CTRI/2017/12/011037 [Registered on: 29/12/2017] Trial Registered Prospectively
Last Modified On: 29/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two different techniques(insulin bolus vs glucose insulin infusion) to control blood glucose levels during surgery 
Scientific Title of Study   Comparitive study between insulin bolus regimen and glucose insulin infusion regimen on effectiveness of intraoperative blood glucose control - a prospective, randomized controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arun P 
Designation  Junior Resident 
Affiliation  Kasturba Hospital 
Address  Department of Anaesthesiology CSOT block, 1st floor, Kasturba Medical College and Hospital Manipal University

Udupi
KARNATAKA
576104
India 
Phone  9600129686  
Fax    
Email  p.arun1991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr HM Krishna 
Designation  Professor 
Affiliation  Kasturba Hospital 
Address  Department of Anaesthesiology CSOT block, 1st floor Kasturba Medical College and Hospital Manipal University

Udupi
KARNATAKA
576104
India 
Phone  9448983314  
Fax    
Email  hmkrishna20032002@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr HM Krishna 
Designation  Professor 
Affiliation  Kasturba Hospital 
Address  Department of Anaesthesiology CSOT block, 1st floor Kasturba Medical College and Hospital Manipal University

Udupi
KARNATAKA
576104
India 
Phone  9448983314  
Fax    
Email  hmkrishna20032002@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Dr Arun P 
Address  Department of Anaesthesiology, CSOT BLOCK, Kasturba Medical College And Hospital, Manipal University 
Type of Sponsor  Other [Self] 
 
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 
Dr Arun P  Kasturba Hospital  Department of Anaesthesiology, CSOT Block, 1st floor, Kasturba Medical College, Manipal University
Udupi
KARNATAKA 		 9600129686

p.arun1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC & KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 diabetes mellitus Preoperative fasting blood glucose value more than 150mg/dl Surgery duration of ≥ 1hour,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INSULIN BOLUS REGIMEN  Regimen as per Poldermann et al in BMC Anaesthesiology 2014 Glucose measurement (mg dl-1) Insulin bolus 72-144 0 IU 144-162 2 IU 162-180 3 IU 180-198 4 IU 198-216 5 IU 216-234 6 IU 234-252 7 IU 252-270 8 IU 270-288 9 IU more than 288 10 IU after doing blood sugar estimation at the end of every hour during surgery 
Comparator Agent  GLUCOSE INSULIN INFUSION REGIMEN  As per vellore regimen in Anesth Analg 2004 Blood glucose (mg dL-1) Treatment Less than 70 Stop insulin if on infusion. Rapid infusion of 100 mL of D5W, measure blood glucose after 15 min 71–100 Stop insulin infuse D5W at 100 mL over 1 hr 101–150 1 U of insulin in 100 mL of D5W over 1 hr 151–200 2 U of insulin in 100 mL of D5W over 1 hr 201–250 3 U of insulin in 100 mL of D5W over 1 hr 251–300 4 U of insulin in 100 mL of D5W over 1 hr More than 300 1 U of insulin for every 1–50 mg more than 100 mg dL-1 in 100 mL of normal saline over 1 hour D5W 5% dextrose in water after doing blood sugar estimation at the end of every hour during surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Type 2 diabetes mellitus
Preoperative fasting blood glucose value >150mg/dl
Surgery duration of ≥ 1hour
 
 
ExclusionCriteria 
Details  Patients with a history of cardiac, respiratory, renal or hepatic failure
Patients undergoing cardiac surgery
Patients having active infection
Patients on steroid therapy
Pregnant female
Patients with serum potassium below the reference range (<3.5 mmol/L) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The proportion of patients in the target glucose levels between 100 mg/dL and 180 mg/dL  Every hour of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Serum potassium levels  1 hour postoperatively 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/01/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Patients with diabetes undergo surgical procedures at a higher rate than nondiabetic people. Major surgical operations require a period of fasting during which oral antidiabetic medications cannot be used and the stress of surgery results in metabolic perturbations that alter glucose homeostasis. Electrolytes imbalance due altered glucose levels (principally potassium, but also magnesium) may increase the risk for arrhythmias. It is therefore imperative that careful attention should be paid to the metabolic status of diabetic patients undergoing surgical procedures. Intraoperative management of blood glucose in diabetes mellitus patients has focused on avoidance of profound hypoglycemia or hyperglycemia. There are many regimens that are described for perioperative blood glucose control each having its own advantages and disadvantages. We plan to compare the intraoperative glycemic levels between insulin bolus regimen and glucose insulin infusion regimen. 
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