| CTRI Number |
CTRI/2016/04/006879 [Registered on: 27/04/2016] Trial Registered Prospectively |
| Last Modified On: |
26/04/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
induction of general anesthesia with two infusion techniques compared with standard technique |
|
Scientific Title of Study
|
A Comparative Study of Two Infusion Doses of Etomidate for Induction Vs. Standard Induction
Dose of Etomidate |
| Trial Acronym |
EIIGA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv |
| Designation |
Junior Resident |
| Affiliation |
|
| Address |
207, harvery house 2 ,hostel complex, gorimedu , jipmer , pondicherry
7/16 vellala street , senneerkuppam,poonamalle
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9566297044 |
| Fax |
|
| Email |
g.rajiv2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satya prakash |
| Designation |
Associate professor |
| Affiliation |
JIPMER |
| Address |
department of anesthesiology and critical care , II floor , old block
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9786184626 |
| Fax |
|
| Email |
munaganuri1975@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajiv G |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
207 Harvey house 2 , hostel complex , JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9566297044 |
| Fax |
|
| Email |
G.RAJIV2008@GMAI.COM |
|
|
Source of Monetary or Material Support
|
| Intra mural research fund
(JIPMER) |
|
|
Primary Sponsor
|
| Name |
Dean Research JIPMER |
| Address |
Office of dean (Research) , Administrative block , I floor |
| 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 Rajiv |
JIPMER |
Department of anesthesiology and critical care , II floor , old block
Pondicherry
PONDICHERRY |
9566297044
G.RAJIV2008@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER ETHIC COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS UNDERGOING SURGERY UNDER GENERAL ANESTHESIA , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ETOMIDATE |
E1- Etomidate 50mcg/kg/min via infusion pump till induction |
| Intervention |
ETOMIDATE |
E1- Etomidate 50mcg/kg/min via infusion pump till induction,
,E2-Etomidate 25 mcg/kg/min via infusion pump till induction
,E3-Etomidate 0.2mg/kg manual bolus dose over 10 seconds |
| Comparator Agent |
ETOMIDATE |
E2-Etomidate 25 mcg/kg/min via infusion pump till induction |
| Comparator Agent |
ETOMIDATE |
E3-Etomidate 0.2mg/kg manual bolus dose over 10 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
AMERICAN PHYSICAL STATUS CLASSIFICATION 1 & 2 |
|
| ExclusionCriteria |
| Details |
Pregnant / Breast feeder
The mentally ill
Drug abuser
Alcohol intoxication
Patients on steroids
If the infusion dose exceeds the standard bolus dose of 0.2mg/kg |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the total dose of etomidate required
for induction with 50mcg/kg/min infusion and
25mcg/kg/min infusion with standard dose 0.2mg/kg
of Etomidate |
our time points are
1) Time required for loss of eye lash reflex
2) Time required to reach entropy value of 50 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the hemodynamic
parameters in between different treatment
regimens.
To assess and compare the time required for
induction in different treatment regimens |
SAMPLING FOR CORTISOL AT BASELINE,
6HRS, 12 HRS, 24HRS, 48HRS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
03/08/2016 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
our aim is to find out the dose required for induction of general anesthesia using etomidate under entropy guidance using low concentration infusion technique. by doing this we want to study whether the dose reduction achieved is associated with reduction in side effects associated with it as many are dose dependant |