| CTRI Number |
CTRI/2020/11/029445 [Registered on: 27/11/2020] Trial Registered Prospectively |
| Last Modified On: |
18/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison of Propofol, Etomidate and a combination of both on the hemodynamic response |
|
Scientific Title of Study
|
Comparative evaluation of Effect of Propofol, Etomidate and a combination of Propofol and Etomidate on the hemodynamic response to induction and endotracheal intubation: a prospective randomized double blinded study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidarshna Viburajah |
| Designation |
Junior resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Junior resident ( second year )
Department of Anaesthesiology and pain medicine
Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra Nagar
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
8056021817 |
| Fax |
|
| Email |
vid7209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkatesh S |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology and pain medicine
Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra Nagar
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9944731220 |
| Fax |
|
| Email |
venkymail2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidarshna Viburajah |
| Designation |
Junior resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of anaesthesiology and pain medicine
Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra Nagar
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
8056021817 |
| Fax |
|
| Email |
vid7209@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vidarshna V |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Ladies hostel V room no 132
Porur
Chennai
600116 |
| Type of Sponsor |
Other [Self] |
|
|
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 Vidarshna V |
Sri Ramachandra Institute of Higher Education and Research |
Department of anaesthesiology and pain medicine
OR complex ( Udayar block and G block )
No. 1 Ramachandra Nagar
Porur
Chennai
TAMIL NADU |
8056021817
vid7209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: N200||Calculus of kidney, (3) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, (4) ICD-10 Condition: K37||Unspecified appendicitis, (5) ICD-10 Condition: S529||Unspecified fracture of forearm, (6) ICD-10 Condition: H729||Unspecified perforation of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A |
Inj.Propofol 2mg/kg bolus intravenous dose
Give during induction of anaesthesia before endotracheal intubation |
| Comparator Agent |
Group B |
Inj.Etomidate 0.3mg/kg bolus intravenous dose
Give during induction of anaesthesia before endotracheal intubation |
| Intervention |
Group C |
Inj.Propofol 1mg/kg + Inj.Etomidate 0.2mg/kg bolus intravenous dose
Give during induction of anaesthesia before endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• ASAI
• Surgery under General Anaesthesia
• Age 18-50 yrs
• Male and Female patients |
|
| ExclusionCriteria |
| Details |
• Patient refusal
• ASA II or higher
• Emergency surgery requiring Rapid Sequence Induction and Intubation
• Allergy to Propofol / Etomidate
• Anticipated Difficult Airway |
|
|
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 |
| hemodynamic response to induction and endotracheal intubation |
Hemodynamic parameters (Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure) will be recorded at pre-induction(baseline),1, 2, and 3 minutes after induction and then at 0, 3, 5 and 10 minutes after endotracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension |
Hemodynamic parameters (Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure) will be recorded at pre-induction(baseline),1, 2, and 3 minutes after induction and then at 0, 3, 5 and 10 minutes after endotracheal intubation. |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/11/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparative evaluation of Propofol, Etomidate and a combination of Propofol and Etomidate on the hemodynamic response to induction and endotracheal intubation: a prospective randomized double blinded study.
We are trying to prove that a combination of Propofol and Etomidate provides good intubating conditions ( effect of propofol - suppressing laryngeal reflexes) while maintaining stable hemodynamics ( effect of Etomidate ) |