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CTRI Number  CTRI/2025/03/082812 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 19/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the Effects of Two Medicines, Esmolol and Labetalol, on Heart rate and Blood Pressure Control During Breathing Tube Removal After Surgery 
Scientific Title of Study   A randomised study to compare the effects of i.v Esmolol vs i.v Labetalol in attenuating hemodynamic response during extubation in Department of Anesthesia, S.M.S Medical College Jaipur 
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 Shriphal Meena 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and Hospital, Jaipur 
Address  Department of Anaesthesia , SMS Medical college, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9928350391  
Fax    
Email  dr.shriphal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shriphal Meena 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College and Hospital, Jaipur 
Address  Department of Anaesthesia , SMS Medical college, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9928350391  
Fax    
Email  dr.shriphal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Snehal Dudekula 
Designation  Junior Resident 
Affiliation  Sawai Man Singh Medical College and Hospital, Jaipur 
Address  Department of Anaesthesia , SMS Medical college, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  8978419820  
Fax    
Email  snehaldudekula3@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, second floor, Dhanvantri complex, SMS medical college and hospitals, Jaipur, India, 302004 
 
Primary Sponsor  
Name  Sawai man singh medical college 
Address  Department of Anaesthesia,second floor,Dhanwantri OPD Block, SMS medical college, Jaipur, India,302004 
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 Shriphal Meena  SMS medical college and Hospitals  Department of Anaesthesiology and critical care, Second floor , Dhanwantri opd block, SMS medical college, Jaipur.
Jaipur
RAJASTHAN 		 9928350391

dr.shriphal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Ethics Committee, SMS medical college and Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj. Esmolol  1.5mg/kg Intravenous drug is given once, 2mins before extubation and observed over a period of 10 mins 
Comparator Agent  Inj. Labetalol  0.25mg/kg Intravenous drug is given once, 2mins before extubation and observed over a period of 10 mins. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients giving consent for general anaesthesia
2.Adult patients of either sex
 
 
ExclusionCriteria 
Details  1.Patients posted for emergency surgery
2.Physical status ASA Class III or more
3.Patients having any significant systemic disorder
4.Patients having comorbid diseases

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart rate  baseline, after giving reversal, at the end of drug administration, 1 min after administration, at the time of extubation, after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
systolic bp, diastolic bp, mean arterial bp  baseline, after giving reversal, at the end of drug administration, 1 min after administration, at the time of extubation, after extubation 
 
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   Phase 3 
Date of First Enrollment (India)   22/03/2025 
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="0"
Months="3"
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  

Background:
During extubation, the process of removing a breathing tube after surgery, patients often experience significant hemodynamic responses such as increased heart rate and blood pressure due to airway stimulation. These responses can cause complications, especially in patients with cardiovascular risks. Beta-blockers like esmolol and labetalol are commonly used to manage these responses due to their cardio-protective properties. However, there is limited evidence comparing their effectiveness and safety during extubation.

Purpose:
The study aims to compare the efficacy of intravenous esmolol and labetalol in attenuating the hemodynamic responses during extubation. The goal is to determine which drug provides better control of heart rate and blood pressure with minimal side effects, ensuring a safer extubation process for patients undergoing general anesthesia.

 
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