| CTRI Number |
CTRI/2022/08/045035 [Registered on: 29/08/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
BLOOD GLUCOSE LEVELS WITH DIFFERENT FLUIDS DURING SURGERY |
|
Scientific Title of Study
|
BLOOD GLUCOSE LEVELS WITH NORMAL SALINE AND RINGER’S LACTATE IN ELECTIVE NON-CARDIAC SURGERIES IN DIABETICS: A RANDOMISED PARALLEL GROUP STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Bohra |
| Designation |
PG student |
| Affiliation |
JNMC Belgaum |
| Address |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
dr.rohitbohra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath C Patil |
| Designation |
Professor |
| Affiliation |
JNMC Belgaum |
| Address |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
mcpatil52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Bohra |
| Designation |
PG Student |
| Affiliation |
JNMC Belgaum |
| Address |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
dr.rohitbohra@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital
Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA |
|
|
Primary Sponsor
|
| Name |
KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospita |
| Address |
KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital Nehru Nagar Belagavi 590010 Karnataka India |
| Type of Sponsor |
Private 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 |
| Rohit Bohra |
Department of Anaestheiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital |
Second Floor OT complex, KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital
Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9810331560
dr.rohitbohra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee on Human Subjects Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline |
Normal Saline used exclusively as intraoperative IV fluid. Blood glucose levels measured every 30 minutes until end of surgery.
Intervention to be stopped earlier if any of the following
1. Hyperglycaemia more than 200mg%
2. Hypoglycaemia less than 80mg%
3. Patient requiring colloids |
| Intervention |
Ringers Lactate |
Ringers Lactate used exclusively as intraoperative IV fluid. Blood glucose levels measured every 30 minutes until end of surgery.
Intervention to be stopped earlier if any of the following
1. Hyperglycaemia more than 200mg%
2. Hypoglycaemia less than 80mg%
3. Patient requiring colloids |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 80 years.
Diabetic patients with normal Renal function test and Liver function test
American Society of Anaesthesiologists physical status II and III
Patients undergoing elective non-cardiac surgeries under regional anaesthesia.
Provides Consent
|
|
| ExclusionCriteria |
| Details |
Patient undergoing emergency surgery.
Pregnant females
Patient who are unable or unwilling to give consent.
Patients requiring colloids (including blood and blood products) at any stage of surgery
Patients who do not fulfil inclusion criteria.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess the Effects of Ringer’s Lactate and Normal Saline on Intraoperative Blood Glucose Levels in Diabetic Patients Undergoing Elective Non-Cardiac Surgeries |
Baseline
30 min
60 min
90 min
120 min
150 min
180 min
End of Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no secondary outcome |
There is no secondary outcome |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2022 |
| Date of Study Completion (India) |
15/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intraoperative glycaemic control has an important role in improving surgical outcomes even in nondiabetic patients. Good glycaemic control and use of insulin to maintain glucose levels has been shown to prevent renal complications in patients undergoing cardiac surgeries as well as myriad cellular and organelle level benefits. Patient outcomes like hospital stay are also impacted by the level of glycaemic control thus, having an economic impact as well.
Most recommendations on peri-operative glucose control mainly focus on defined blood glucose ranges, anti-hyperglycaemic medications and continuous insulin infusions10. Surprisingly few studies include choice of appropriate IV fluids as part of peri-operative blood glucose management.
The goal of this study is to observe the effect of 0.9% saline and Ringer’s Lactate on intra-operative blood glucose levels in diabetic patients undergoing elective non-cardiac surgeries. |