CTRI Number |
CTRI/2024/02/062662 [Registered on: 15/02/2024] Trial Registered Prospectively |
Last Modified On: |
12/02/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A Comparative study of vital parameters of two different IV anaesthetic agents and combination of both during intubation |
Scientific Title of Study
|
A Comparative study of hemodynamic response of propofol, etomidate and admixture of etomidate-propofol during endotracheal intubation - A prospective randomized 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 Soundharya T |
Designation |
Junior resident |
Affiliation |
BJ medical college , Asarwa , Ahmedabad |
Address |
New PG hostel phase 1, civil hospital campus,
F3,first floor department of Anesthesiology. Ahmedabad
GUJARAT 380016
Ahmadabad GUJARAT 380016 India |
Phone |
8056355004 |
Fax |
|
Email |
sindhu66@ymail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr smita R Engineer |
Designation |
professor |
Affiliation |
BJMC civil hospital asarwa ahmedabad |
Address |
F3 block 1st floor department of anesthesiology civil hospital asarwa , ahmedabad
Ahmadabad GUJARAT 380016 India |
Phone |
9825504948 |
Fax |
|
Email |
seng_90@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr smita R Engineer |
Designation |
professor |
Affiliation |
BJMC civil hospital asarwa ahmedabad |
Address |
F3 block 1st floor department of anesthesiology civil hospital asarwa , ahmedabad
Ahmadabad GUJARAT 380016 India |
Phone |
9825504948 |
Fax |
|
Email |
seng_90@yahoo.com |
|
Source of Monetary or Material Support
|
Civil hospital BJ medical college asarwa Ahmedabad |
|
Primary Sponsor
|
Name |
Civil hospital Ahmedabad |
Address |
7th floor, 7th block health and family welfare department new sachavalay , gandhinagar , gujarat |
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 Soundharya T |
Civil hospital Ahmedabad |
ENT, orthopaedics, major surgical OT, urology OT Ahmadabad GUJARAT |
8056355004
sindhu66@ymail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
The Institutional ethics commitee BJ medical college and civil hospital , Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: Z049||Encounter for examination and observation for unspecified reason, (2) ICD-10 Condition: R69||Illness, unspecified, (3) ICD-10 Condition: R69||Illness, unspecified, (4) ICD-10 Condition: R69||Illness, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
admixture of propofol, etomidate |
Inj propofol 1mg/kg i.v and etomidate 0.15mg/kg are induction drugs used to compare the hemodynamic responses during intubation
|
Intervention |
etomidate |
inj etomidate 0.3mg/kg iv is used as induction agent and their hemodynamic responses are studied with admixture of propofol and etomidate |
Intervention |
propofol |
inj propofol 2-3mg/kg i.v is the induction agent used for comaparing with etomidate and their hemodynamic responses are evaluated |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1.Patients willing to consent for the study
2.Elective surgery under general anaesthesia with endotracheal intubation
3.ASA class 1, 2, 3
4.Either gender |
|
ExclusionCriteria |
Details |
1.Difficult airway
2.Pregnancy
3.severe cardiopulmonary or liver disease , hypotension , shock
4.Presence of known primary or secondary adrenal insufficiency
5.Patient on steroid medication
6.Allergic to propofol and etomidate
7.Patients BMI equal or greater than 40kg/m2 |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To compare the hemodynamic parameters (HR, SBP,DBP,MBP) |
From start of induction till 1hour & thereafter 10 minutes postop |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the adverse effects at the time of induction such as myoclonus , pain on injection .
To compare perioperative complications such as intraoperative arrhythmias , desaturation , postoperative nausea & vomiting and thrombophlebitis |
from induction till 24 hours of postoperative period |
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
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 2 |
Date of First Enrollment (India)
|
22/02/2024 |
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="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
|
Endo-tracheal intubation is the gold standard and safest
method for protecting the airway, delivering anesthetic gases and ensuring
protection against aspiration. Stress response during laryngoscopy and
intubation leads to hemodynamic changes like hypertension and ischemic heart
disease. The unavoidable effects of laryngoscopy and tracheal intubation
include dysrhythmia, hypertension, myocardial ischemia, infarction, hypoxia, hypercapnia and increased intracranial pressure and increased intraocular pressure.
There is no ideal induction agent in term of providing a
stable hemodynamics during endotracheal intubation. Also, there are very few
published studies in the literature that have compared the physiological effect
of combination of induction agents during laryngoscopy and intubation.
Propofol is one the commonly used drug for induction of
general anesthesia. This is a short acting intravenous anesthetic agent.
Unwanted complication associated with this drug is hemodynamic instability and
cardiovascular complications. Propofol can lead to bradycardia by increasing
the production and release of nitrous oxide. It also causes pain at injection site.
Etomidate is a hypnotic agent which is cardio-stable with
no release of histamine. It is short acting drug, used for induction and
maintenance of anesthesia. The most important side effects of etomidate are
burning sensation at injection site, myoclonic movements, nausea and vomiting. Induction of anesthesia by Etomidate would lead to a stable hemodynamic
condition while performing laryngoscopy and endotracheal intubation.
Very few studies regarding combination of propofol and
etomidate focused on hemodynamic changes during anesthesia induction and
intubation are available. This study is planned to evaluate and compare the
effects of etomidate, propofol and combination of etomidate and propofol on hemodynamic parameters during induction, laryngoscopy and endotracheal
intubation.
|