| CTRI Number |
CTRI/2024/05/067100 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of genetic profile on hemodynamic changes following etomidate induction. |
|
Scientific Title of Study
|
Correlation of polymorphisms in pharmacogenetic candidate genes with dose variability and cardiovascular parameters during induction of general anaesthesia with etomidate |
| 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 Annam Lakshmanan |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no 304 3rd floor BL Taneja block Department of AnaesthesiologyMaulana Azad Medical College Central Delhi 110002 India
Central
DELHI
110002
India |
| Phone |
7094465353 |
| Fax |
|
| Email |
Annam199714@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKirti Nath Saxena |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak hospital |
| Address |
Room no 304 3rd floor BL Taneja block Department of Anaesthesiology Maulana Azad medical college Central delhi110002 India
Central
DELHI
110002
India |
| Phone |
23238058 |
| Fax |
|
| Email |
kirtinath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annam Lakshmanan |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical college and associate Lok Nayak hospital |
| Address |
Room no 304 3rd floor BL Taneja block Department of Anaesthesiology Maulana Azad Medical College Central Delhi 110002 India
Central
DELHI
110002
India |
| Phone |
7094465353 |
| Fax |
|
| Email |
Annam199714@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college and associated Lok Nayak hospital ,New Delhi,India 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college and associated Lok Nayak hospital |
| Address |
Maulana Azad Medical College and Lok Nayak hospital,JLN marg,New Delhi 110002 |
| Type of Sponsor |
Government 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 annam lakshmanan |
Maulana Azad medical college and associated Lok Nayak hospital |
Room no : 304,third floor ,Department of Anaesthesiology ,Maulana Azad medical college,Lok Nayak hospital ,JLN marg,New Delhi -110002
Central
DELHI |
7094465353
Annam199714@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical college and associated hospital ,(Lok Nayak ,GB pant institute of post graduate medical education and research hospital ,guru Nayak eye centre , New Delhi 110002,Institutional ethical committee |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the criteria for American society of Anaesthesiologist ,physical status 1-2
BMI less than 30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Hypertension,
patient who have received corticosteroids in the last 6 months,pregnancy
psychiatry illness or patients suffering from intellectual disabilities
History of etomidate allergy
History of psychoactive drugs
Neurosurgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of the induction dosage of etomidate during general anaesthesia with genetic polymorphism of GABRA2,CYP2C9,UGT1A9 and UGT1A7 |
Baseline ,0 seconds ,30 seconds,60 seconds,90 seconds,120 seconds,150 secs ,180 secs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) changes in the cardiovascular parameters during etomidate induction and correlating with generic polymorphisms of GABRA2,CYP2C9,UGT1A9,UGT1A7 |
Baseline ,0 seconds ,30 seconds,60 seconds,90 seconds,120 seconds,150 seconds ,180 seconds |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
01/06/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will be correlating the induction dosage and cardiovascular changes during general anaesthesia with etomidate with genetic polymorphism of GABRA2,CYP2C9,UGT1A7 genes in the Indian population, we will also be correlating the change in cortisol level after etomidate administration with genetic polymorphism of GABRA2,CYP2C9 and UGT1A7 genes. 102 patients will be enrolled in our study.The patient will be explained about the study and written informed consent will be obtained. The parameters such as heart rate, blood pressure ,BIS values will be recorded for 5 minutes after the patient enters the operation theatre and during etomidate administration and will be rechecked at 30 seconds ,60 seconds ,90 seconds,120 seconds,150 seconds and 180 seconds.samples for cortisol and genetic analysis will be taken .At the end of the observation period ,rets of anaesthetic management will be done at the discretion of attending anaesthesiologist . |