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CTRI Number  CTRI/2025/02/080780 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative clinical study to see the changes in hemodynamic responses to laryngoscopy and intubation with the use of two induction agents 
Scientific Title of Study   A COMPARATIVE STUDY OF HEMODYNAMIC RESPONSES TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION FOLLOWING INDUCTION WITH PROPOFOL VERSUS ETOMIDATE IN PATIENTS UNDERGOING MAJOR ABDOMINAL SURGERIES. 
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 MUHSINA RAHMAN 
Designation  Post Graduate Trainee student 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup metro

Kamrup
ASSAM
781032
India 
Phone  9365739517  
Fax    
Email  muhsina10rahman@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajib Hazarika 
Designation  Professor 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup metro

Kamrup
ASSAM
781032
India 
Phone  9864063140  
Fax    
Email  rajibhazarika8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajib Hazarika 
Designation  Professor 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup metro

Kamrup
ASSAM
781032
India 
Phone  9864063140  
Fax    
Email  rajibhazarika8@gmail.com  
 
Source of Monetary or Material Support  
Gauhati Medical College And Hospital, Bhangagarh,Guwahati,Kamrup Metro, Assam, India, PIN:781032 
 
Primary Sponsor  
Name  Dr Muhsina Rahman 
Address  Department of Anaesthesiology and critical care, Gauhati Medical College and hospital, Bhangagarh, Guwahati, 781032, Kamrup, Assam, India 
Type of Sponsor  Other [SELF] 
 
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 Muhsina Rahman  Gauhati Medical College and Hospital  Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Guwahati
Kamrup
ASSAM 		 9365739517

muhsina10rahman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE, GAUHATI MEDICAL COLLEGE AND HOSPITAL, GUWAHATI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Etomidate  To compare the hemodynamic responses of etomidate (0.3mg/kg body weight)intravenously at baseline, after induction of general anesthesia, during laryngoscopy and intubation, at 1min, at 3 minutes, at 5 minutes, and at 10 minutes after intubation in patients undergoing major abdominal surgeries  
Intervention  Propofol  To compare the hemodynamic responses of propofol(2mg per kg body weight) intravenously at baseline, after induction of general anesthesia during laryngoscopy and intubation, at 1 min, at 3 minutes, at 5 minutes and at 10 minutes after intubation in patients undergoing major abdominal surgeries. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients belonging to ASA grade 1-2
2. Patients belonging to age group 18-60 years.
3. Patients who are posted for elective major abdominal surgeries.
4.Patients who are willing to give informed written consent for surgery. 
 
ExclusionCriteria 
Details  1. Patients with known allergic history of the drugs of study.
2. Patients with known cardiovascular diseases.
3. Patients with any other co-morbid conditions.
4. Patients with anticipated difficult intubation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the various hemodynamic responses in each group, namely - heart rate, systolic blood pressure, diastolic blood pressure, oxygen saturation.  Before induction, after induction, during intubation, after 1,3,5 and 10 minutes post intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the adverse effects (if any) of the drugs studied in each group  At baseline, after 1 minute of administration of drugs, after 5 minutes of administration of drugs, after 10 minutes of administration of drugs 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   03/03/2025 
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   Most of the surgical procedures are carried out in stage 3 of general anaesthesia, i.e., stage of surgical anaesthesia Induction of GA is a critical step as during this phase, the patients are susceptible to sudden hemodynamic instability. Presently, the most common way of inducing anaesthesia is the use of intravenous anaesthetic agents.   Propofol, etomidate, ketamine, thiopentone and midazolam are namely a few agents used for induction. Propofol is the most commonly used drug for induction of GA at present times. It has gained popularity due to some of its favourable properties like – short half-life which causes rapid elimination of drug from circulation, it further leads to good post anaesthesia recovery, anti-emetic properties that causes less incidence of post operative nausea vomiting. However, hemodynamic instabilities like hypotension, cardiovascular instability, and profound respiratory depression (in higher doses) are the major unfavourable effects of this drug. Etomidate, on the other hand as an inducing agent is found to have minimal or no effects on cardio-respiratory system, as seen on previous studies. However, pain on injection, thrombophlebitis and incidence of myoclonus are some of the adverse effects of this drug. Though etomidate fell out of use in the past due to its major adverse effect of causing adrenocortical suppression, but it regained its popularity as a safe anaesthetic inducing agent, more particularly in critically ill patients who are hemodynamically unstable. Considering the common use of propofol and etomidate as inducing agents, this study is taken up for comparing the effects of these two drugs on hemodynamics of the patient undergoing major abdominal surgeries under GA.
References
1.Attenuation of hemodynamic response to induction and intubation using propofol or etomidate Dr. Nikesh Kumar Roshan, Dr. Prakash Kumar , https://ejmcm.com/article_19843.html   

 2.Comparison of haemodynamic response to laryngoscopy and endotracheal intubation following induction of general anaesthesia    https://doi.org/10.18231/2394-4994.2018.0038 

 3.Masoudifar M, Beheshtian E. Comparison of cardiovascular response to laryngoscopy and tracheal intubation after induction of anesthesia by Propofol and Etomidate. J Res Med Sci. 2013 Oct;18(10):870-4. PMID: 24497858; PMCID: PMC3897071. 

 4.Wan C, Hanson AC, Schulte PJ, Dong Y, Bauer PR. Propofol, Ketamine, and Etomidate as Induction Agents for Intubation and Outcomes in Critically Ill Patients: A Retrospective Cohort Study. Crit Care Explor. 2021 May 24;3(5):e0435. doi: 10.1097/CCE.0000000000000435. PMID: 34046636; PMCID: PMC8148417. 

 5.A COMPARATIVE STUDY ON THE HEMODYNAMIC EFFECTS OF PROPOFOL AND ETOMIDATE USED AS INDUCING AGENTS IN GENERAL ANAESTHESIA
Dr. Sunil Kumar Jain, Dr.Sudhir Tichkule . doi:10.31838/jcdr.2022.13.05.94




 
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