CTRI Number |
CTRI/2022/02/039898 [Registered on: 01/02/2022] Trial Registered Prospectively |
Last Modified On: |
30/12/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Comparative study |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
A clinical trial to compare the effect of two sleep causing drugs namely etomidate and propofol-phenylephrine combination on heart rate and blood pressure in adult patients undergoing open heart surgeries |
Scientific Title of Study
|
Hemodynamic profiles of etomidate vs propofol-phenylephrine combination for induction of anaesthesia in adult cardiac surgical patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Molli Kiran |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bhopal |
Address |
AIIMS, Saket nagar, Bhopal AIIMS, Saket nagar, Bhopal Bhopal MADHYA PRADESH 462020 India |
Phone |
9441497323 |
Fax |
|
Email |
mvr934@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Molli Kiran |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bhopal |
Address |
AIIMS, Saket nagar, Bhopal AIIMS, Saket nagar, Bhopal Bhopal MADHYA PRADESH 462020 India |
Phone |
9441497323 |
Fax |
|
Email |
mvr934@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Molli Kiran |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, Bhopal |
Address |
AIIMS, Saket nagar, Bhopal AIIMS, Saket nagar, Bhopal Bhopal MADHYA PRADESH 462043 India |
Phone |
9441497323 |
Fax |
|
Email |
mvr934@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Molli Kiran |
Address |
Arvind Vihar |
Type of Sponsor |
Other [Self] |
|
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 |
Molli Kiran |
All India Institute of Medical Sciences, Bhopal |
Department of Anaesthesiology, Modular Operation theatre complex, Third floor Bhopal MADHYA PRADESH |
9441497323
mvr934@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Adult ASA II-IV patients undergoing elective cardiac surgeries involving valve replacement and/or coronary artery bypass grafting surgeries who are willing to participate in the study. |
|
ExclusionCriteria |
Details |
1. Patients with known allergy to the study drugs
2. Emergency surgeries
3. Patients with anticipated difficult airway and patients who require more than 2 attempts or more than 30 seconds for direct laryngoscopy
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure every 30 sec for the first ten minutes after induction |
first ten minutes after anaesthesia induction |
|
Secondary Outcome
|
Outcome |
TimePoints |
number of extra doses of phenyl ephrine needed in both the groups |
first ten minutes of induction |
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
07/02/2022 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
18/12/2023 |
Estimated Duration of Trial
|
Years="0" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Propofol and etomidate are the two commonly used induction agents in anaesthesia practice. In patients who are critically ill and in patients with cardiovascular disease, etomidate is preferred as it causes less hypotension compared to propofol. But retrospective studies have proposed an association between the use of etomidate for anaesthesia induction and increased risk of mortality, morbidity in septic or critically ill patients.(1) In spite of these concerns, etomidate is favored for induction of anaesthesia in cardiac surgery patients, in whom hemodynamic stability immediately after induction of anaesthesia is paramount. The important factors producing cardiovascular depression due to propofol are direct myocardial depression and decreased systemic vascular resistance (SVR). Phenylephrine is a pure alpha agonist which increases venous return and SVR which can counter propofol induced vasodilation. In non-cardiac surgery, studies have shown that phenylephrine mixed with propofol when administered for induction of anaesthesia reduces the hypotension due to propofol. (2,3,4) Our primary hypothesis is that if propofol-phenylephrine combination has non-inferior hemodynamic profiles to that of etomidate, the former can replace the latter. |