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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 



 

 

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