| CTRI Number |
CTRI/2025/02/080802 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of two anesthesia drugs, etomidate and propofol, on blood pressure during induction for General anaesthesia in patients undergoing liver transplant surgery |
|
Scientific Title of Study
|
Effect of etomidate versus
propofol on hemodynamic parameters for induction in recipients undergoing
liver transplant surgery: a randomized control 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 Ishan Verma |
| Designation |
Senior Resident |
| Affiliation |
Institute Of Liver and Biliary Sciences |
| Address |
Institute of Liver and Biliary Sciences, Department Of Anaesthesia, phase2, Anaesthesia classroom ,room1 ,Vasant Kunj New Delhi
New Delhi
DELHI
110070
India |
| Phone |
7987340168 |
| Fax |
|
| Email |
ishanverma8653@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Institute Of Liver and Biliary Sciences |
| Address |
Institute of Liver and Biliary Sciences, Department Of Anaesthesia, Academic Block room 4 ,Vasant Kunj , New Delhi
New Delhi
DELHI
110070
India |
| Phone |
8089337600 |
| Fax |
|
| Email |
doc.anilyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Institute Of Liver and Biliary Sciences |
| Address |
Institute of Liver and Biliary Sciences, Department Of Anaesthesia, Academic Block room 4 ,Vasant Kunj , New Delhi
New Delhi
DELHI
110070
India |
| Phone |
8089337600 |
| Fax |
|
| Email |
doc.anilyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences, Vasant Kunj , New Delhi,India. PIN code-110070 |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
Institute of Liver and Biliary Sciences, Vasant Kunj , New Delhi,India. PIN code-110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ishan Verma |
Institute of liver and biliary sciences |
Institute of liver and biliary sciences, Vasant Kunj Delhi
New Delhi
DELHI |
7987340168
ishanverma8653@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF LIVER AND BILIARY SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate |
Etomidate as induction agent
Dose: 0.2 to 0.3 mg per kg
Frequency: Once
Route: intravenous
Duration: once |
| Comparator Agent |
Propofol |
Propofol as induction agent
Dose: 2 to 3 mg per kg
Frequency: Once
Route: intravenous
Duration: once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60 years Patients undergoing Liver Transplant Recipient Surgery |
|
| ExclusionCriteria |
| Details |
Patients who do not consent for the study.
Recipients for Acute liver failure and acute on chronic liver failure
Patients with preexisting cardiac disease
Patients with Cirrhotic Cardiomyopathy
Patients having allergy to propofol or etomidate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study change in mean arterial pressure during induction every minute till 10
minutes. |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare hemodynamic parameters: HR-heart rate, SBP- systolic blood pressure, DBP- Diastolic blood pressure, CO- cardiac output, SV- stroke volume, SVV- Stroke volume variation during induction every minute till 10 minutes.
|
10 minutes after induction |
To compare use of vasopressor during induction every minute till 10 minutes.
|
10 minutes after induction |
| To compare rate of complication like myoclonus and pain on injection during induction every minute till 10 minutes. |
10 minutes after induction |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
15/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Hypothesis : Etomidate will give better hemodynamic stability as induction agent than propofol Study population: Patients will be assigned to two groups of 25 each.
Group A (n=25) (Induction with Propofol) Group B (n=25) (Induction with Etomidate) Study design: Prospective randomized controlled trial Study period: 6 months |