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CTRI Number  CTRI/2024/12/078154 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between oral Ivabradine and Intravenous Esmolol for their efficacy in achieving pressor response during intubation, in ASA grade I patients 
Scientific Title of Study   Attenuation of pressor response to laryngoscopy and endotracheal intubation with oral Ivabradine versus intravenous Esmolol in American society of Anesthesiologist physical status grade I patients - Open label randomised control trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  sundharalingam senthilraj 
Designation  postgraduate 
Affiliation  government medical college, nalgonda. 
Address  Department of pharmacology, Government medical college. Nalgonda.
Department of pharmacology
Nalgonda
TELANGANA
-508001
India 
Phone  8012177178  
Fax    
Email  lingas2984@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tadvi Naser Ashraf 
Designation  Head of the department and Professor 
Affiliation  government medical college, nalgonda. 
Address  Department of pharmacology Government medical college, Nalgonda.

Nalgonda
TELANGANA
-508001
India 
Phone  9052734381  
Fax    
Email  nasertadvi@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  sundharalingam senthilraj 
Designation  postgraduate 
Affiliation  government medical college, nalgonda. 
Address  Department of Pharmacology Government medical college, Nalgonda - 508001

Nalgonda
TELANGANA
-508001
India 
Phone  8012177178  
Fax    
Email  lingas2984@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Government medical college 
Address  Near RTC Bus Stand, Gollaguda, Nalgonda - 508001 
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 
sundharalingam senthilraj  Government medical college and hospital  Department of Pharmacology
Nalgonda
TELANGANA 
8012177178

lingas2984@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical college ethic committee GMC.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H948||Other specified disorders of ear in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ESMOLOL  Intravenous esmolol is administered 1mg/kg 2 minutes before induction. Esmolol is a short acting beta-blocker that rapidly reduces the heart rate and is used in acute settings where rapid heart rate control is necessary 
Intervention  IVABRADINE  Ivabradine is administered orally at a dosage of 5mg, 2 hours before endotracheal intubation.It selectively inhibits the If current in the sinoatrial node, reducing heart rate without affecting myocardial contractility or intracardiac conduction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  a.American Society of Anesthesiologists (ASA) –Physical Status grade I
b.Patients with Mallampatti class I and II
c.Patients with Normal ECG
d.Patients Scheduled for elective non- cardiac surgery requiring endotracheal intubation. 
 
ExclusionCriteria 
Details  a.Patients refusal or not consented to participate in the study.
b.Patient with previous H/O Chest Pain/ Palpitations/Syncope
c.Patient with H/o Respiratory Problems
d.Patient with Hepatic or renal Problems
e.Patient with Known allergies to Esmolol or Ivabradine
f. Patient with History of cardiac conduction abnormalities.
g.Patient with ECG abnormalities
h.Patient with difficult airway
i.Patient with Heart rate less than 60/minute and Systolic blood pressure less than 100mmHg
j.Patient with total duration of laryngoscopy and intubation more than 20 seconds
k.Patient with Mallampatti class III and IV
Pregnant and lactating women 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean Heart rate,
Mean Systolic blood pressure
Mean diastolic blood pressure 
At base level, after study drug, after induction, after intubation, 1st minute, 3rd minute, 5th minute, 8th minute, 10th minute, 1st hour and 2nd hour  
 
Secondary Outcome  
Outcome  TimePoints 
Adverse drug reaction  after 12 hours of study drug 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   14/01/2025 
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="6"
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  

Airway management is a critical skill for anesthesiologists, particularly during laryngoscopy and endotracheal intubation, which often trigger a cardiovascular stress response. This response, characterized by transient hypertension, tachycardia, and elevated serum catecholamines, can result in serious cardiovascular complications, especially in high-risk patients. Effective management of this pressor response is therefore essential to ensure patient safety and optimize outcomes during surgery.

Esmolol, a cardio-selective beta-blocker with a short half-life, has been widely studied for its ability to attenuate the pressor response and maintain hemodynamic stability. Conversely, Ivabradine, a selective inhibitor of the "If" current in the sinoatrial node, offers a unique mechanism of reducing heart rate without affecting myocardial contractility or blood pressure. Unlike beta-blockers, Ivabradine is suitable for use in patients with contraindications to beta-blockers, such as those with bronchial asthma, diabetes, or normotensive conditions.

While studies have established the individual efficacy of Esmolol and Ivabradine in blunting the cardiovascular stress response to intubation, no direct comparative study has been conducted to evaluate their relative effectiveness. This randomized controlled trial aims to bridge this gap by comparing oral Ivabradine and intravenous Esmolol in attenuating hemodynamic responses to laryngoscopy and intubation in ASA Grade I patients undergoing elective surgeries. The findings will provide evidence-based insights into optimal pharmacological interventions to minimize perioperative cardiovascular risks and refine anesthetic protocols.

 RELEVANCE OF RESEARCH PROPOSAL TO PUBLIC HEALTH:

1. Understanding the comparative effectiveness of pharmacological interventions will directly contributes to enhancing patient safety during endotracheal intubation.

2. Identifying the most effective agent for blunting the pressor response ensures the delivery of high-quality care to patients, reduce the risk of cardiovascular complications associated with this procedure.

3. Anesthetic protocols play a pivotal role in ensuring positive perioperative outcomes. This research has the potential to influence and optimize anesthesia protocols. 

4. By providing evidence-based insights into the comparative efficacy of esmolol and Ivabradine, the study will contribute to refining anesthesia practices, promoting standardization, and improving the overall quality of care.

 


 
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