| CTRI Number |
CTRI/2017/08/009438 [Registered on: 21/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
15/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Comparison of the effects of
three intravenous drugs (propofol,etomidate and a 1:1 mixture of propofol and etomidate) on blood pressure,heart rate during injection of study drug and on insertion of endotracheal tube inside trachea during general anaesthesia . |
|
Scientific Title of Study
|
Comparison of propofol,etomidate and a 1:1 mixture of propofol and etomidate for hemodynamic stability and response to direct laryngoscopy and endotracheal intubation in general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad Hospital and Research Institute,Kelambakkam |
| Address |
Department of Anaesthesiology, A5 villa,First floor,
Chettinad Health city,
OMR
Kelambakkam,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9489404818 |
| Fax |
|
| Email |
pugalenthi08@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad Hospital and Research Institute,Kelambakkam |
| Address |
Department of Anaesthesiology, A5 villa,First floor,
Chettinad Health city,
OMR
Kelambakkam,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9489404818 |
| Fax |
|
| Email |
pugalenthi08@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Arun Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Chettinad Hospital and Research Institute,Kelambakkam |
| Address |
Department of Anaesthesiology, A5 villa,First floor,
Chettinad Health city,
OMR
Kelambakkam,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9489404818 |
| Fax |
|
| Email |
pugalenthi08@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute,Chettinad Health city,Old Mahabalipuram Road,Kelambakkam,
Chennai-603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital and Research InstituteKelambakkamChennai |
| Address |
Chettinad Health City
OMR Kelambakkam Chennai |
| 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 |
| P Karthick |
Chettinad Hospital and Research Institute,Kelambakkam |
Departmentof Anaesthesiology Chettinad Hospital and Reasearch Institute, Chettinad Health City, OMR,Kelambakkam,Chennai
Kancheepuram
TAMIL NADU |
9941480008
karthikpandian18@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II patients undergoing surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
unwilling patients,allergy to study drug,peripheral vascular disease,pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response to study drug,intubation response to study drug |
1 minute,3 minute and 5 minutes after injection of study drug
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| depth of anaesthesia,incidence of pain and myoclonus |
1 minute after injection of study drug |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2015 |
| Date of Study Completion (India) |
06/06/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="4"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of the study is to compare the effects of propofol,etomidate and a 1:1 mixture of propofol & etomidate on hemodynamic stability and during intubation in patients undergoing general anaesthesia. |