| CTRI Number |
CTRI/2020/09/027812 [Registered on: 15/09/2020] Trial Registered Prospectively |
| Last Modified On: |
12/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing the difference between Propofol & Etomidate in causing changes to vital parameters of trauma patients while facilitating tracheal intubation for artificial breathing |
|
Scientific Title of Study
|
Comparison of intravenous Propofol and Etomidate in attenuating the hemodynamic response during laryngoscopy and intubation in trauma patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen Singhadia |
| Designation |
PG 3rd Resident |
| Affiliation |
Dr S.N Medical College |
| Address |
Office ,department of Anaesthesia ,Dr S.N Medical College ,Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9461295398 |
| Fax |
|
| Email |
drpsinghadiya1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Rajpurohit |
| Designation |
Professor |
| Affiliation |
Dr S.N Medical College,jodhpur |
| Address |
Office ,Trauma ICU,MDM hospital ,Dr S.N Medical College ,Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9928060011 |
| Fax |
|
| Email |
drvikasrajpurohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Singhadia |
| Designation |
PG 3rd Resident |
| Affiliation |
|
| Address |
Office of department of anesthesia, 1st floor,Mahatma Gandhi Hospital,S.N.Medical college,Jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9461295398 |
| Fax |
|
| Email |
drpsinghadiya1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sampurnanand Medical College,jodhpur,Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr Sampurnand Medical College |
| Address |
Dr Sampurnanand Medical College ,Jodhpur,342902 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 |
| Dr Praveen Singhadia |
Trauma centre ,MDM hospital |
Department Of anaesthesia ,MDM hospital ,
Jodhpur
RAJASTHAN |
9461295398
drpsinghadiya1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T149||Unspecified injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Propofol and Etomidate |
In study we will do comparison of intravenous Propofol 2mg/kg body weight and Etomidate 0.3mg/kg body weight in attenuating The hemodynamic response during laryngoscopy and intubation in trauma patients
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for patients :
Patients of either sex with age between 20 to 60 years and body weight 30 to 80 kg belonging to ASA grade 1 and 2, admitted in trauma center receiving no narcotics or sedative drug and who are hemodynamically stable before induction will be included in the study
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria :
Patient who refuse to participate, patients in shock or if they have any H/o convulsion, allergy to the drug used, respiratory, cardiac, hepatic, or renal dysfunction or if they belong to ASA Grade 3 or 4 will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine any difference in objective hemodynamic response (HR, SBP, DBP, MAP) due to IV Propofol and IV Etomidate used during laryngoscopy and intubation in trauma patients. |
Baseline values of bp ,pulse and MAP ,then one minute after laryngoscopy,then after 5 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine any difference in objective hemodynamic response (HR, SBP, DBP, MAP) due to IV Propofol and IV Etomidate used during laryngoscopy and intubation in trauma patients. |
Baseline values of bp ,pulse and MAP ,then one minute after laryngoscopy,then after 5 minutes. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2020 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a study to compare intravenous propofol and intravenous etomidate to blunt the response of heart rate and blood pressure during laryngoscopy and intubation in trauma patient admitted in trauma center |