| CTRI Number |
CTRI/2025/12/099463 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares two medicines, ketamine and etomidate, used during emergency treatment in patients with very low blood pressure (shock). It will see how each medicine affects blood pressure and heart function to find which is safer and more effective. |
|
Scientific Title of Study
|
This study compares the effects of ketamine and etomidate on blood pressure and heart function during anesthesia induction in patients with decompensated shock. |
| 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 Dhruva Yadiyal |
| Designation |
DNB EMERGENCY MEDICINE STUDENT |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Room no. 823, Department of Emergency Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
Room no. 823, Department of Emergency Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
South West
DELHI
110029
India |
| Phone |
8310395725 |
| Fax |
|
| Email |
yadiyal.dhruva10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhruva Yadiyal |
| Designation |
DNB EMERGENCY MEDICINE STUDENT |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Room no. 823, Department of Emergency Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
Room no. 823, Department of Emergency Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
South West
DELHI
110029
India |
| Phone |
8310395725 |
| Fax |
|
| Email |
yadiyal.dhruva10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhruva Yadiyal |
| Designation |
DNB EMERGENCY MEDICINE STUDENT |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Room no. 823, Department of Emergency Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
Room no. 823, Department of Emergency Medicine, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.
South West
DELHI
110029
India |
| Phone |
8310395725 |
| Fax |
|
| Email |
yadiyal.dhruva10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Department of emergency medicine
VMMC and Safdarjung Hospital
New Delhi-110029 |
| 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 Dhruva Yadiyal |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Room no. 823, Department of Emergency Medicine, New Emergency Block, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi – 110029, India.
South
DELHI |
8310395725
yadiyal.dhruva10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Etomidate Induction |
Drug – Etomidate administered intravenously as a single bolus dose of 0.3 mg/kg. The total duration of this intervention is a single administration at the time of induction. observed for 1 hour. |
| Intervention |
ketamine induction |
Drug – Ketamine hydrochloride administered intravenously as a single bolus dose of 1.0 mg/kg. The total duration of this intervention is a single administration at the time of induction. observed for 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient more than 18 years undergoing emergency induction for intubation in emergency department
Systolic blood pressure less than 90 mmhg |
|
| ExclusionCriteria |
| Details |
patient with known allergy to ketamine and etomidate
Patient presenting as already intubated |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the changes in systolic blood pressure and heart rate before and after induction with ketamine versus etomidate in decompensated shock patients |
Time points in minutes - 0,5,10,15,30,45,60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the need of additional vasopressor or change in the dose of existing vasopressor of ketamine group with etomidate group |
Additional vasopressors required or not in the 1st 1 hour after induction |
|
|
Target Sample Size
|
Total Sample Size="79"
Sample Size from India="79"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Previous retrospective and prospective observation studies, randomized trials and meta-analysis have reported conflicting results. Some find that Ketamine is better and others report that there isn’t much difference between the two and few suggest that ketamine results in more hemodynamic instability. Paucity of study in Indian population exists and it’s underexplored in patients with shock. In practice there is a bias of using ketamine in high shock index patients, so with this study we try to decrease this bias and have equal chances of using ketamine or etomidate by randomisation. we will compare the peri-induction hemodynamic effects of ketamine and etomidate in patients with decompensated shock |