| CTRI Number |
CTRI/2025/11/097089 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To Compare Efficacy Of The Injection Propofol Vs Injection Etomidate During General Anaesthesia In Adult Group |
|
Scientific Title of Study
|
To Compare Efficacy Of The Injection Propofol Vs Injection Etomidate During General Anaesthesia In Adult |
| 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 RAGHU DHIRUBHAI SURANI |
| Designation |
First year resident of department of anaesthesia |
| Affiliation |
Gujrat adani institute of medical science |
| Address |
RTO circle street No - 1, B- 10,Bhuj-370001
Kachchh
GUJARAT
370001
India |
| Phone |
8320960473 |
| Fax |
|
| Email |
raghusurani5727@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIRALI TRIVEDI |
| Designation |
Associate professor of department of Anaesthesia |
| Affiliation |
Gujrat adani institute of medical science |
| Address |
Department of anaesthesiology, G.k.General hospital Gujarat Adani Institute Of Medical Sciences,Bhuj Department of anaesthesiology, G.k.General hospital Gujarat Adani Institute Of Medical Sciences,Bhuj Kachchh GUJARAT 370001 India
Kachchh
GUJARAT
370001
India |
| Phone |
94261 38081 |
| Fax |
|
| Email |
nirali_7291@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR RAGHU DHIRUBHAI SURANI |
| Designation |
First year resident of department of anaesthesia |
| Affiliation |
Gujrat adani institute of medical science |
| Address |
RTO circle street No - 1, B- 10,Bhuj-370001
Kachchh
GUJARAT
370001
India |
| Phone |
8320960473 |
| Fax |
|
| Email |
raghusurani5727@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gujarat Adani Institute of Medical Science |
|
|
Primary Sponsor
|
| Name |
Gujarat Adani Institute of Medical Science |
| Address |
G.K.General Hospital ,GAIMS Campus Bhuj, Gujrat 370001 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Raghu Dhirubhai Surani |
G.K. General Hospital, Bhuj |
Department of Anaesthesia ( Gujrat Adani Institute of Medical Science)
Kachchh
GUJARAT |
8320960473
raghusurani5727@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K272||Acute peptic ulcer, site unspecified, with both hemorrhage and perforation, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: N648||Other specified disorders of breast, (4) ICD-10 Condition: H679||Otitis media in diseases classified elsewhere, unspecified ear, (5) ICD-10 Condition: M479||Spondylosis, unspecified, (6) ICD-10 Condition: K37||Unspecified appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Etomidate 0.3mg/kg intravenous |
Inj Etomidate will be given to patients. |
| Intervention |
Inj Propofol 2mg/kg intravenous.
|
Inj Propofol will be given to patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
Elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to drug
Pregnancy and lactation
Patient refusal for participation in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Check The Effect Of Injection Propofol And Injection Etomidate |
From Starting Of Induction,Intra-op And Post-op Up To 10 Minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/11/2025 |
| 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 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
|
Induction of anaesthesia is a crucial period during anaesthesia delivery, often associated with significant hemodynamic fluctuations. Hypotension and arrhythmias during induction can affect patient outcomes, especially those with co-morbid conditions. Propofol is a frequently used induction agent due to its rapid onset and smooth induction; however, it is well documented to cause marked reduction in arterial pressure and peripheral resistance. Etomidate, on the other Hand Is non barbiturate hypnotic agent which provides a more stable hemodynamic profile during induction, making it desirable in patients with poor cardiovascular reserve. This study aims to directly compare the effects of Propofol and Etomidate on hemodynamics during induction of anaesthesia in a population of ASA I and II adults undergoing elective surgeries under general anaesthesia. The results of this study may help guide anaesthesiologist in choosing the most appropriate induction agent in their practice, particularly for patients at risk of hemodynamic instability.
|