| CTRI Number |
CTRI/2026/04/109144 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparitive study of two medications (Epinephrine versus Phenylephrine) used to manage low blood pressure during intubation procedure. |
|
Scientific Title of Study
|
Comparative study of Epinephrine versus Phenylephrine as Push-Dose Pressors for Peri-Intubation Hypotension |
| 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 IRTIQA SHEIKH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GANDHI MEDICAL COLLEGE |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
Sultania Rd, near Hamidia Hospital, Royal Market, Bhopal, Madhya Pradesh 462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8287995923 |
| Fax |
|
| Email |
irtiqa.em@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR IRTIQA SHEIKH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GANDHI MEDICAL COLLEGE |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
Sultania Rd, near Hamidia Hospital, Royal Market, Bhopal, Madhya Pradesh 462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8287995923 |
| Fax |
|
| Email |
irtiqa.em@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR IRTIQA SHEIKH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GANDHI MEDICAL COLLEGE |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
Sultania Rd, near Hamidia Hospital, Royal Market, Bhopal, Madhya Pradesh 462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8287995923 |
| Fax |
|
| Email |
irtiqa.em@gmail.com |
|
|
Source of Monetary or Material Support
|
| GANDHI MEDICAL COLLEGE BHOPAL |
|
|
Primary Sponsor
|
| Name |
GANDHI MEDICAL COLLEGE BHOPAL |
| Address |
Sultania Rd, near Hamidia Hospital, Royal Market, Bhopal, Madhya Pradesh 462001 |
| 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 |
| IRTIQA SHEIKH |
GANDHI MEDICAL COLLGE and associated Hamidia Hospital ,BHOPAL |
Department of Emergency medicine, GMC and associated Hamidia hospital,Sultania Rd, Royal Market, Bhopal, Madhya Pradesh 462001
Bhopal
MADHYA PRADESH |
8287995923
irtiqa.em@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preloaded Syringe A with Inj Epinephrine 10 mcg per ml |
The staff nurse would administer 1ml from preloaded syringe just before administration of induction agents this will constitute one dose of respective PDP. It can be repeated every 2 to 5 min as required depending on treating clinician’s decision max of 3 doses will be given
In case of occurrence of serious adverse events and complications hypertension bradycardia tachycardia and cardiac arrest they will be treated as per standard protocols of management for the same.
|
| Comparator Agent |
Preloaded Syringe B with Inj Phenylephrine 100mcg per ml |
The staff nurse would administer 1ml from preloaded syringe just before administration of induction agents this will constitute one dose of respective PDP. It can be repeated every 2 to 5 min as required depending on treating clinician’s decision max of 3 doses will be given
In case of occurrence of serious adverse events and complications hypertension bradycardia tachycardia and cardiac arrest they will be treated as per standard protocols of management for the same. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than equal to 18 years
All patients undergoing RSI in Emergency department
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Not giving consent
Pregnant patients
Patients in cardiac arrest
Perintubation SBP more than 90 mm Hg
Patients with ongoing ventricular arrythmias
Patients already intubated before presenting to ED
|
|
|
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 |
To compare the effect of Epinephrine and Phenylephrine as push dose pressors for peri intubation hypotension
|
Responder – Episodes that achieved a 25% increase in SBP at or before T4 will be classified as responder
Non responder – Episodes that achieved a 25% increase in SBP by T4 will be classified as non-responders
T4 is defined as 10 min after giving first dose of PDP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No of doses of PDP required in each group for responder |
No of doses of PDP required in each group for increasing SBP to more than 25 percent at T4 |
| To compare the safety of PDP in the two groups |
Record the PDP related adverse events in both the groups |
| To assess the requirement of continuous vasopressor support within 4 hours of PDP administration |
Need of continuous vasopressor support within 4 hours of PDP administration |
| To compare incidence of cardiac arrest within 1 hour of PDP |
Incidence of cardiac arrest within 1 hour of PDP
|
| To compare in hospital mortality within 1 week |
1 week mortality rate in both arms
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/05/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Endotracheal intubation is a
common lifesaving procedure in critically ill patients, and is often
complicated by adverse events, mostly cardiovascular instability, which is
directly linked to an increase in in-hospital mortality. The use of push dose
pressors as a method to mitigate these complications has gained attention in
the recent years. Though their usage has been well established in the
ansaethesia world, their use in the emergency department has been perpetuated
without a full scope of knowledge surrounding the effectiveness and safety
profile. Up to this point, the endorsement of push-dose pressors (PDPs) has
been overwhelmingly based on anecdotal or observational data. The paucity of
research behind push-dose vasopressors comparing Epinephrine and Phenylephrine
thus made the demand for randomized trials evident. |