| CTRI Number |
CTRI/2024/11/077145 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the hemodynamic changes between two induction agents used for intubation in ICU : Etomidate vs Propofol. A Randomised Control Study |
|
Scientific Title of Study
|
A comparison of hemodynamic changes between Etomidate vs Propofol as induction agents during intubation in ICU A Randomised Control 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 SURAVI SAMANTA |
| Designation |
DRNB RESIDENT |
| Affiliation |
FORTIS ESCORTS HOSPITAL, FARIDABAD, HARYANA |
| Address |
FORTIS ESCORTS HOSPITAL FARIDABAD, NEELAM BATA ROAD, FARIDABAD, HARYANA
INTENSIVE CARE UNIT (ICU), SECOND FLOOR, FORTIS ESCORTS HOSPITAL, FARIDABAD.
Faridabad
HARYANA
121001
India |
| Phone |
08900332282 |
| Fax |
|
| Email |
suravisamanta93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMANDEEP SINGH |
| Designation |
ADDITIONAL DIRECTOR, CRITICAL CARE MEDICINE |
| Affiliation |
FORTIS ESCORTS HOSPITAL, FARIDABAD, HARYANA |
| Address |
FORTIS ESCORTS HOSPITAL, FARIDABAD, NEELAM BATA ROAD, FARIDABAD, HARYANA.
INTENSIVE CARE UNIT (ICU), SECOND FLOOR, FORTIS ESCORTS HOSPITAL FARIDABAD.
Faridabad
HARYANA
121001
India |
| Phone |
9910052552 |
| Fax |
|
| Email |
dr.amandeepsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SURAVI SAMANTA |
| Designation |
DRNB RESIDENT |
| Affiliation |
FORTIS ESCORTS HOSPITAL, FARIDABAD, HARYANA |
| Address |
FORTIS ESCORTS HOSPITAL FARIDABAD, NEELAM BATA ROAD, FARIDABAD, HARYANA
INTENSIVE CARE UNIT, SECOND FLOOR, FORTIS ESCORTS HOSPITAL, FARIDABAD.
Faridabad
HARYANA
121001
India |
| Phone |
08900332282 |
| Fax |
|
| Email |
suravisamanta93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fortis Escorts Hospital,Faridabad.
Neelam Bata Rd,AC Nagar,New Industrial Township, Faridabad, Haryana, India. Pin-121001. |
|
|
Primary Sponsor
|
| Name |
FORTIS ESCORTS HOSPITAL FARIDABAD |
| Address |
FORTIS ESCORTS HOSPITAL, FARIDABAD, NEELAM BATA ROAD, FARIDABAD, HARYANA. POST-121001 |
| 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 |
| DR SURAVI SAMANTA |
FORTIS ESCORTS HOSPITAL |
INTENSIVE CARE UNIT (ICU), SECOND FLOOR, FORTIS ESCORTS HOSPITAL, FARIDABAD. NEELAM BATA ROAD, FARIDABAD, HARYANA 121001
Faridabad
HARYANA |
8900332282
suravisamanta93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FORTIS HOSPITAL LIMITED |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ETOMIDATE |
Hemodynamic comparison between Etomidate and Propofol as induction agents during intubation in ICU. Study to be conducted over one year. |
| Comparator Agent |
PROPOFOL |
Haemodynamic comparison between Etomidate and Propofol as induction agents during intubation in ICU. Study to be conducted over one year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 yrs of either sex admitted in ICU requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Age less than 18yrs requiring endotracheal intubation
2. Post cardiac arrest patients
3. Contraindications to Propofol or Etomidate
4. Known pregnancy
5. Lack of equipoise
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of the two induction agents-propofol and etomidate on haemodynamic instability like cardiovascular collapse or respiratory failure in ICU subjects. |
Outcome observed at time interval of 1minute, 5 minutes, 15 minutes and 30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Ease of Intubation Score
2.Change in oxygenation status
3.Injury during intubation
|
Immediately after intubation, within a time frame of 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="112" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2024 |
| Date of Study Completion (India) |
31/08/2025 |
| Date of First Enrollment (Global) |
20/11/2024 |
| Date of Study Completion (Global) |
31/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Participants undergoing intubation, hemodynamic variations with each induction agent, any advert peri-intubation event will be documented and compared. Hemodynamic variations caused by the drugs plays an important role in determining the peri-intubation mortality and morbidity. We also hypothesized here that the identification of modifiable variables can have an impact on the participant’s outcome and help to mitigate the incidences and severity of peri-intubation cardiovascular collapse. |