| CTRI Number |
CTRI/2018/04/013409 [Registered on: 23/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
we are comparing effect of etomidate,propofol and combination of propofol and ketamine on patients vitals at start of anaesthesia |
|
Scientific Title of Study
|
A comparison of propofol, etomidate and Ketofol means ketamine propofol 1:3 ratio as induction agent
A Randomized comparative clinical study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenakshi machhar |
| Designation |
junior resident |
| Affiliation |
RNT MEDICAL COLLEGE AND ATTACHED HOSPITAL,MAIN OT |
| Address |
RNT Medical college
department of anaesthesiology
udaipur Rajasthan
RNT Medical college
department of anaesthesiology
Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929760889 |
| Fax |
|
| Email |
meenakshimachhar25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khemraj Meena |
| Designation |
Professor |
| Affiliation |
RNT MEDICAL COLLEGE AND ATTACHED HOSPITAL,DEPARTMENT OF ANAESTHESIOLOGY |
| Address |
RNT Medical college
department of anaesthesiology
Udaipur Rajasthan
RNT Medical college
department of anaesthesiology
Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
khemraj10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenakshi machhar |
| Designation |
junior resident |
| Affiliation |
RNT MEDICAL COLLEGE AND ATTACHED HOSPITAL,DEPARTMENT OF ANAESTHESIOLOGY |
| Address |
RNT Medical college
department of anaesthesiology
Udaipur Rajasthan
RNT Medical college
department of anaesthesiology
Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929760889 |
| Fax |
|
| Email |
meenakshimachhar25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology |
| Address |
RNT Medical college and attached hospital udaipur rajasthan |
| 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 |
| Meenakshi machhar |
MB governmentt hospital |
RNT Medical college and attached hospital
department of anaesthesia
MAIN OT
udaipur rajasthan
rajasthan
Udaipur
RAJASTHAN |
9929760889
meenakshimachhar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee RNT Medical College and controller and attached hospitals |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I and II age 18-60yrs both male and female all elective general surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparison of propofol etomidate and Ketofol |
propofol(2mg/kg)IV etomidate(0.3mg/kg)IV and ketamine(0.5mg/kg)+ propofol(1.5mg/kg)IV 1:3 ratio as induction agent given in 60 seconds studied haemodyanamics for 10 min after giving drugs. |
| Comparator Agent |
propofol etomidate ketofol |
propofol(2mg/kg)IV etomidate(0.3mg/kg)IV and ketamine(0.5mg/kg)+ propofol(1.5mg/kg)IV 1:3 ratio as induction agent given in 60 seconds studied haemodyanamics for 10 min after giving drugs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist grade I and II of either sex, weighing 35-70kg elected for general surgeries under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patients with history ofadrenal insufficiency, asthma,hypertension,suspected difficult airway,
receiving general anaesthesia during the previous week,receiving steroid during the past 6 months,sensitivity to etomidate, propofol or ketamine,sensitivity to egg and soya,pregnancy,
Morbidly obese,chronic inflammatory diseases and serious psychiatric,endocrine or neurological illnesses.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparision of haemodynamics in three groups |
Haemodynamics were recorded baseline value,after induction,0 min after intubation,1 minute after intubation, 3 min after intubation, 5 min after intubation and 10 min after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of side effects and any adverse effects |
any adverse effects of drug like pain on injection and myoclonus movement was seen during induction |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2016 |
| Date of Study Completion (India) |
17/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
comparing propofol,etomidate and ketofol as an induction agent and to compare haemodynamic changes during induction and intubation with etomidate, propofol and ketamine +propofol (ketofol) and to evaluate any adverse effects of study drugs.We Concluded that combination of ketamine plus propofol has better haemodynamic stability than etomidate and propofol as an induction agent with no side effects. Hence, combination proved to be significantly better than either propofol or etomidate alone |