FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/03/012821 [Registered on: 23/03/2018] Trial Registered Retrospectively
Last Modified On: 13/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study intraoperative blood glucose level changes between obese and non-obese non-diabetic patients undergoing craniotomy surgery under general anaesthesia 
Scientific Title of Study   Intraoperative blood Glucose level cnanges between obese and non-obese non-diabetic patients undergoing general anaesthesia for craniotomy surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soumya Chakrabarti 
Designation  Junior Resident 
Affiliation  Department of Anaesthesiology,IPGME&R &SSKMH 
Address  Bangur Institute of Neurosciences,Anaesthesia department,Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata .

Kolkata
WEST BENGAL
700020
India 
Phone  9477137462  
Fax    
Email  drsoumyachakrabarti@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sampa Dutta Gupta 
Designation  Professor 
Affiliation  Dept. of Cardiac Anaesthesiology, Nil Ratan Sircar Medical College & Hospital 
Address  4th floor, UNB block, NRS medical college 138 A.J.C. Bose Road, Sealdah, Kolkata, West Bengal 700020

Kolkata
WEST BENGAL
700014
India 
Phone  9433834317  
Fax    
Email  sdg_1603@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Indrani Chakraborty 
Designation  Assistant Professor 
Affiliation  Deparment of Anaesthesiology, Bangur Institute of Neurology, IPGME&R & SSKMH 
Address  Bangur Institute of Neurosciences,Anaesthesia department,Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata .

Kolkata
WEST BENGAL
700020
India 
Phone  9830662797  
Fax    
Email  indranimitra7@gmail.com  
 
Source of Monetary or Material Support  
Bangur Institute of neurology, Institute of post graduate medical education and research, kolkata 
 
Primary Sponsor  
Name  Department of Anaesthesiology Bangur Institute of Neurology IPGMER SSKMH 
Address  Shambhu Nath Pandit Street, Near Burdwan Chemist, Bhowanipur, Kolkata, West Bengal 700025 
Type of Sponsor  Government medical college 
 
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 
soumya chakrabarti  Bangur Institute of Neurology, IPGME&R & SSKMH  Room 1 and 2, Neurosurgery OT Complex, Department of Anaesthesiology,Shambhu Nath Pandit Street, Near Burdwan Chemist, Bhowanipur, Kolkata, West Bengal 700025
Kolkata
WEST BENGAL 
9477137462

drsoumyachakrabarti@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of IPGME&R  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  changes in perioperative BLOOD GLUCOSE levels,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II
2. non-diabetic obese patients undergoing craniotomy surgery under general anaesthesia
3. non-diabetic non-obese patients undergoing craniotomy surgery under general anaesthesia
 
 
ExclusionCriteria 
Details  1. unwilling patients
2. patients with severe cardiovascular, respiratory, renal and endocrine disease including diabetes mellitus
3. all emergency surgeries
4. surgeries other than neurosurgical procedures
5. operations under regional anaesthesia
6. hemodynamically unstable patients
7. pregnancy
8. ASA physical status III or more
9. age <18 yrs and >65 yrs 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
blood glucose level changes will be more in obese than in non-obese population and the change will increase with the duration of surgery  preoperative single value, just after induction of anaesthesia and thereafter at half an hour interval till the end of operation, single value postoperatively 30 minutes after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
insulin requirement will be more in obese than in non-obese patients and the requirement will increase with the duration of surgery  180 minutes 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/03/2015 
Date of Study Completion (India) 31/05/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   no publication 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Background: Surgery causes a considerable metabolic stress in both diabetic and nondiabetic patient, but the   severity of stress induced hyperglycemia is considerably high in diabetic  patient  . In
non-diabetic subjects the stress response is more in obese population than in non-obese due to the presence of insulin resistance. The
severity of surgery as well as the type of anesthesia influence the magnitude of the stress response The study was undertaken to observe the effect of stress   in obese and non-obese non-diabetic patients
undergoing craniotomy under general anesthesia.

Methods: A Prospective randomized parallel group study was done on a total of 100 patients. They were divided into two groups non-obese
patients and obese patients comprising of 50 patients in each group depending on their BMI. 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. Number of hyperglycaemic episode and total insulin consumption
in both group were the primary outcome of study.

Results: 36% patients in obese population developed at least one
episode of hyperglycemia (CBG ≥ 150 mg/dL) whereas only 20% patients
in non-obese population had hyperglycemia episode .   The relative
risk of  hyperglycemic in obese was higher than non-obese [ 1.80 (95%
CI 0.92 to 3.51)]. The total intraoperative  and postoperative
insulin requirement were significantly higher  in non-obese population
 than obese  and the difference was statistically significant (p=0.02)
Conclusions: We conclude that stress induced hyperglycemic response in
patients undergoing craniotomy surgery under general anaesthesia is
common in both   diabetic and non-diabetic population  and the
relative risk  is more in  obese patients than non-obese.
 
 
Close