FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/02/003342 [Registered on: 04/02/2013] Trial Registered Retrospectively
Last Modified On: 01/02/2013
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   blood sugar level in head injury patients during operation 
Scientific Title of Study   Perioperative glycemic status of non diabetic adult traumatic brain injury patients undergoing craniotomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof N K Gozi 
Designation  Professor & Head 
Affiliation  Institute of Post Graduate Medical Education & Research and SSKM Hospital, 
Address  Department of Anaesthesiology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244 AJC Bose Road Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  nitiskumargozi@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amitava Layek 
Designation  Resident 
Affiliation  Department of Anaesthesiology, Institute of Post Graduate Medical Education & Research, Kolkata 
Address  Room No:404, Junior Doctors Hostel, 242 AJC Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  amitavalayek@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amitava Layek 
Designation  Resident 
Affiliation  Department of Anaesthesiology, Institute of Post Graduate Medical Education & Research, Kolkata 
Address  Room No:404, Junior Doctors Hostel, 242 AJC Bose Road, Kolkata

Kolkata
WEST BENGAL
700020
India 
Phone    
Fax    
Email  amitavalayek@gmail.com  
 
Source of Monetary or Material Support  
The trial is being conducted in IPGME&R, Kolkata without any external funding support 
 
Primary Sponsor  
Name  Institute of Post Graduate Medical Education Research Kolkata 
Address  Department of Anaesthesiology, IPGME&R and SSKM Hospital, 244 AJC Bose Road, Kolkata-700020 WB,India 
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 
Dr Amitava Layek  Department of Anaesthesiology  IPGME&R and SSKM Hospital, 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL 
9433748598

amitavalayek@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Traumatic brain injury patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Nondiabetic patients of ASA physical status I, II or III of age group 25-60 years of either sex undergoing craniotomy under general anaesthesia. 
 
ExclusionCriteria 
Details  Unwilling patients
Patients with known history of diabetes mellitus, impaired postprandial glucose tolerance (2h postprandial blood glucose> 126mg/dL) and impaired fasting glucose (fasting blood glucose> 106mg/dL)
Patients with severe respiratory, cardiovascular, neurological or renal disease
ASA physical status IV and V
Haemodynamically unstable patients
Pregnancy
Body weight < 40 kg
Body weight > 80 kg
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
intraoperative blood glucose levels in nondiabetic adult patients of TBI undergoing craniotomy in the perioperative period  1. Before induction of anaesthesia
2. Thirty minutes interval till the end of surgery
3. One hour after conclusion of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.the blood glucose variability in these patients in the intraoperative period.
2. incidence of at least one episode of intra operative hyperglycemia.
 
Throughout the intraoperative period 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   29/01/2013 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Physiologic alterations due to surgical stress are widespread and affect all organ system of the body.1 Of all these changes, the metabolic changes appear to be proportional to the severity of the surgical trauma with plasma cortisol and blood glucose concentration rising slightly during minor surgical procedures but significantly during major intraabdominal operations.2 During surgery there is insulin resistance due to rise of levels of counter regulatory hormones like glucagon, growth hormone, cortisol and catecholamines which can be indirectly observed by the incidence of hyperglycemia.3

However, hyperglycemia is almost always detrimental, associated with increased morbidity and mortality even in nondiabetic patients4-6. Several studies showed that hyperglycemia is a poor prognostic marker after traumatic brain injury.7 But none of these studies addressed the incidence of hyperglycemia in the perioperative period in non diabetic patients. 

The present study will be undertaken to know the prevalence of perioperative hyperglycemia in adult patients of traumatic brain injury undergoing craniotomy.

Specific objectives of the study:

1.      To know the intraoperative blood glucose levels in nondiabetic adult patients of TBI undergoing craniotomy in the perioperative period

2.      To know the blood glucose variability in these patients in the intraoperative period.

3.      To know the incidence of at least one episode of intra operative hyperglycemia.

 
Close