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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
changes in perioperative BLOOD GLUCOSE levels, |
|
Intervention / Comparator Agent
|
|
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. |