| CTRI Number |
CTRI/2025/07/091403 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Insulin Lispro Infusion and the Vellore Regimen for Managing Blood Sugar During Emergency Surgery in Diabetic Patients |
|
Scientific Title of Study
|
Comparing the efficacy of insulin lispro infusion vs Vellore regimen for optimizing perioperative blood sugar level in diabetic patients undergoing emergency surgery: A randomized clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ezhilrajan |
| Designation |
professor and HOD |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Department of Anaesthesiology, First floor, A block, Aarupadai Veedu Medical College, Kirumampakkam
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9843030074 |
| Fax |
|
| Email |
ezhilrajan96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shanmugavalli E |
| Designation |
professor |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Department of Anaesthesiology, First floor, A block, Aarupadai Veedu Medical College, Kirumampakkam
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
vallijegan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ezhilrajan |
| Designation |
professor and HOD |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Department of Anaesthesiology, First floor, A block, Aarupadai Veedu Medical College, Kirumampakkam
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9843030074 |
| Fax |
|
| Email |
ezhilrajan96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital , pondicherry. |
|
|
Primary Sponsor
|
| Name |
aarupadai veedu medical college and hospital |
| Address |
aarupadai veedu medical college hospital , kirumampakkam, pondicherry - 607403 |
| 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 |
| Dr ezhilrajan |
Aarupadai veedu medical college and hospital |
Department of Anaesthesiology, First floor, A block, Aarupadai Veedu Medical College, Kirumampakkam
Pondicherry
PONDICHERRY |
09843030074
ezhilrajan96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E131||Other specified diabetes mellituswith ketoacidosis, (2) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INSULIN LISPRO INFUSION |
Will be receiving lispro insulin infusion in titrated doses according to blood sugar for control of blood sugar |
| Intervention |
nil |
nil |
| Comparator Agent |
Vellore regimen |
Will be receiving regular insulin on titrated doses for control of blood sugar by vellore regimen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2,3
RBS greater than 100 mg per dl
BMI LESS THAN 35 |
|
| ExclusionCriteria |
| Details |
Patients unwilling to enroll for the study
Patients with a history of allergy to the drugs used in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of Vellore regimen vs insulin lispro infusion for optimizing perioperative blood sugar level in diabetic patients undergoing emergency surgery |
180 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor serum electrolytes changes.
|
180 MINUTES |
| To monitor hypoglycaemic episodes. |
180 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After informed consent all the diabetic
patients planned for surgery are included, their current glycemic status (Blood
Sugar AC AND PC valve, HbA1c), Blood pressure, BMI and medication for Co-morbid are
recorded. Group V Will be receiving regular insulin on
titrated doses for control of blood sugar by vellore regimen , Group L Will be receiving lispro insulin
infusion for control of blood sugar. Plan in Pre-operative period Control of Glycemic status with diabetic
management plan, capillary blood glucose Level will be monitored regularly,
fluid and electrolyte maintenance according to Individual patients will be
done.
Intra-operative: For all patient’s capillary blood glucose
level will be checked before induction,
every hourly intra- operative blood sugar monitoring, change in blood sugar valve will be adjusted with subcutaneous
or by intravenous insulin. Plan to have individualized goal directed therapy.
Post Operative Plan to maintain glycemic status (Blood Sugar
value of 6-10mmol per L), fluid and electrolytes control and insulin
therapy for each patient will be monitor and recorded for data collection. |