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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Traumatic brain injury patients, |
|
Intervention / Comparator Agent
|
|
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. |