| CTRI Number |
CTRI/2024/09/073981 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the changes in hemodynamic parameters during induction and intubation with injection etomidate and injection propofol |
|
Scientific Title of Study
|
Comparision Of Hemodynamic Parameters Of Injection Etomidate and Injection Propofol During Induction and Intubation Under General Anesthesia: A Randomised Double Blind 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 |
DR ABRUM BHARATH KUMAR YADAV |
| Designation |
FIRST YEAR RESIDANT |
| Affiliation |
Sir t hospital |
| Address |
Junior residant, department of anaesthesialogy,sir t hospital, government medical College bhavnagar, bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8500889588 |
| Fax |
|
| Email |
ababram95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHILPA DOSHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sir takhtsingji hospital |
| Address |
Department of anesthesiology, sir takhtsingji hospital, government medical college, bhavanagar, gujarat, india, 364001.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428810763 |
| Fax |
|
| Email |
drshilpadoshi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ABRUM BHARATH KUMAR YADAV |
| Designation |
FIRST YEAR RESIDANT |
| Affiliation |
Sir t hospital |
| Address |
Junior residant, department of anaesthesialogy,sir t hospital, government medical College bhavnagar, bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8500889588 |
| Fax |
|
| Email |
ababram95@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR, GUJARAT, INDIA, 364001 |
|
|
Primary Sponsor
|
| Name |
Government medical college bhavnagar |
| Address |
department of anaesthesialogy, sir t hospital, bhavnagar, 364001 |
| 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 ABRUM BHARATH KUMAR YADAV |
Sir t hospital |
Department of Anesthesiology, Government medical college, Bhavnagar, 364001.
Bhavnagar
GUJARAT |
8500889588
ababram95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj etomidate |
Etomidate 0.3mg per kg given intravenously during induction and the hemodynamic changes are recorded for every 2 minutes till 10 minutes after intubation |
| Intervention |
Inj propofol |
Dose 2mg per kg given intravenously during induction and hemodynamic changes are recorded for every 2 min till 10 minutes after intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Weight 40-80 kg.
American Society Of Anaesthesiologist(ASA) physical status l, ll and lll . |
|
| ExclusionCriteria |
| Details |
1.Patient who does not given written informed
consent.
2.Known history of allergy to Propofol or
Etomidate. •
3,Pregnant and lactating woman.
4.Obese patients and patients with predicted difficult intubation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate
Systolic blood pressure
Diastolic blood pressure
Mean arterial pressure |
Heart rate
Systolic blood pressure
Diastolic blood pressure
Mean arterial blood pressure measured before inducion.before intubation, after intubation, 2 minutes,4 minutes, 6 minutes, 8 minutes, 10 minutes after intubation respectively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Complications like intra operative & post operative nausea & vomiting, |
Time of induction to 24 hours after operation |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
21/09/2024 |
| 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 Yet Recruiting |
| 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
|
Rapid induction and hemodynamic stability with minimal side effects are the most important characteristics desired from an ideal induction agent. * Etomidate and propofol are the well known anaesthetic agents routinely used for the intravenous induction in general anaesthesia. * The two drugs however, have different induction characteristics . Hence, this study is to compare their effects on hemodynamics to help choose the better induction agent in this subset of patients. |