| CTRI Number |
CTRI/2025/06/089836 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A comparison between Propofol and Etomidate which are drugs used to initiate general anesthesia effect the blood sugar levels during surgery in diabetic and non diabetic patients |
|
Scientific Title of Study
|
A comparison of General Anesthesia Induction with Propofol versus Etomidate on blood glucose concentration in Diabetic and Non Diabetic patients during elective surgical procedure. A Randomized Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachel Mary Louis |
| Designation |
Post Graduate Resident Department of Anesthesia |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Anesthesia St Johns Medical College Hospital Sarjapur Marathahalli road beside Bank of Baroda John Nagar Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9048698204 |
| Fax |
|
| Email |
rachel.mary@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arpana Kedlaya |
| Designation |
Associate Professor Department of Anesthesia |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Anesthesia St Johns Medical College Hospital Sarjapur Marathahalli road beside Bank of Baroda John Nagar Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9945346123 |
| Fax |
|
| Email |
drarpanak@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpana Kedlaya |
| Designation |
Associate Professor Department of Anesthesia |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Anesthesia St Johns Medical College Hospital Sarjapur Marathahalli road beside Bank of Baroda John Nagar Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India |
| Phone |
9945346123 |
| Fax |
|
| Email |
drarpanak@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia St Johns Medical College Hospital Sarjapur Marathahalli Road beside Bank of Baroda John Nagar Koramangala Bengaluru Karnataka India 560034 |
|
|
Primary Sponsor
|
| Name |
Rachel Mary Louis |
| Address |
Department of Anesthesia Operation Theater Complex 2nd floor A Block St Johns Medical College Hospital Sarjapur Marathahalli road beside Bank of Baroda John Nagar Koramangala Bengaluru India 560034 |
| Type of Sponsor |
Other [Self] |
|
|
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 Arpana Kedlaya |
St Johns Medical College Hospital |
Operation Theater Complex 2nd floor A Block
Bangalore
KARNATAKA |
9945346123
drarpanak@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee St Johns Academy of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood Glucose monitoring |
Using a glucometer a baseline blood glucose value is measured prior to the general anesthesia induction process. This serves as the baseline value to compare for any rise or fall in blood glucose after induction of anesthesia |
| Comparator Agent |
Comparison between Propofol versus Etomidate on blood glucose concentration |
Controlled diabetic with Hba1c levels of less than 7 and non diabetic patients undergoing general anesthesia are randomized into 2 groups where half of them are induced with Propofol and the other half with Etomidate. Then blood glucose levels are measured 5, 15 and 30 minutes after induction is compared with a baseline value taken prior to the induction process. The hemodynamic parameters are also monitored every 5 minutes till 30 minutes after induction and compared with a baseline preinduction value. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologists class 1 and 2 which include Non diabetic and controlled diabetic
individuals
2. Patients scheduled for elective surgeries under General Anesthesia |
|
| ExclusionCriteria |
| Details |
1.Individuals with associated comorbidities like
Hypertension on Alpha or Beta Blockers
2.Difficult Airway
3.Emergency and Laparoscopic Surgeries
4.Sevoflurane Induction
5.Patients on any medications that alter blood glucose levels such as steroids.
6.Patients with Psychiatric Illness
7.Patients with allergy to Study Drugs.
8.Obese patients with a Body Mass Index of more than 30 percentage
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of induction doses of Propofol and Etomidate on Blood Glucose concentration in Diabetic and Non-Diabetic Patients during Elective Surgical Procedures |
Blood glucose will be monitored prior to general anesthesia induction and then at 5, 15 and 30 minutes respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess Haemodynamic response to induction doses of Propofol and Etomidate
2.To ascertain for any correlation between blood sugar and hemodynamic parameters on Induction with Propofol and Etomidate
|
Hemodynamic parameters will be monitored prior to induction and then at every 5 minutes starting from general anesthesia induction till 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
26/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Background Surgical
stimulus is a noxious stimulus which produces various hemodynamic responses as
well as alteration of blood glucose level. Acute
hyperglycemia in the perioperative period is associated with significantly
increased morbidity, complications and worsens prognosis even in the patients
who had normal glucose tolerance test. Despite
a multitude of observation, varying opinions are available regarding
hypergylcemia response of anesthetic agents and techniques.Both Propofol and Etomidate have similar mechanism of action but may not have similar effects on the body in
response to surgical stress.A comparison
between these induction agents and the effect they have blood glucose can
greatly affect intraoperative management of diabetic patients.
Objective and need for study To
compare the effect of induction doses of Propofol and Etomidate on Blood
Glucose concentration in Diabetic and Non-Diabetic Patients during Elective
Surgical Procedures.
Methodology Subjects will be randomly assigned to one of two
groups .Each group will consist of 80
participants, equally divided into 40 diabetic and 40 non-diabetic patients.NPO
status and Consent will be confirmed on the morning of the surgery. Vital parameters Heart Rate (HR), Systolic Blood
Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP),
Oxygen Saturation (SpO2) and will be monitored and baseline recordings will be
noted. Preinduction General Random Blood Sugar(GRBS) will be documented with a
glucometer. Patients will be preoxygenated and premedicated prior to induction. Induction
done with either Injection Propofol 2mg/kg or Injection Etomidate 0.3mg/kg . GRBS will be measured using
Glucometer at 5 minutes , 15 minutes and 30 minutes after induction. 25g of glucose or dextrose is used for treatment of
intraoperative hypoglycemia for blood glucose less than 80mg/dL as per institutional
protocols. Hyperglycemia more than 180mg/dL will be
treated with sliding scale regiment starting with 4IU for GRBS of 180 to 220
and an increase of 2IU for every 40mg/dL increase in GRBS. Haemodynamic Parameters HR, SBP, DBP, MAP, SpO2, and End Tidal Carbon
Dioxide (ETCO2) will be recorded. |