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CTRI Number  CTRI/2025/07/092130 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of lignocaine, labetalol and esmolol for blunting of the physiological changes seen during laryngoscopy and intubation under general anaesthesia, i.e. rise in blood pressure, heart rate, and serum cortisol levels. 
Scientific Title of Study   Comparison of intravenous lignocaine, esmolol and labetalol for attenuation of hemodynamic and stress response to laryngoscopy and endotracheal intubation under general anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushant 
Designation  Post graduate student 
Affiliation  ABVIMS and Dr. Ram manohar lohia hospital, New Delhi 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS and Dr. RML hospital, New Delhi.

Central
DELHI
110001
India 
Phone  8054997165  
Fax    
Email  sushant911100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Lalita Chaudhary 
Designation  Director Professor 
Affiliation  ABVIMS and Dr. Ram manohar lohia hospital, New Delhi 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS and Dr. RML hospital, New Delhi.

Central
DELHI
110001
India 
Phone  9968299710  
Fax    
Email  lalitachaudhary055@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lalita Chaudhary 
Designation  Director Professor 
Affiliation  ABVIMS and Dr. Ram manohar lohia hospital, New Delhi 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS and Dr. RML hospital, New Delhi.

Central
DELHI
110001
India 
Phone  9968299710  
Fax    
Email  lalitachaudhary055@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr. RML hospital, New delhi, 110001 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Sushant  ABVIMS and Dr. RML hospital, New Delhi  Room no. 301, Department of Anaesthesia, ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi, 110001
Central
DELHI 		 8054997165

sushant911100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ABVIMS and Dr, RML Hospital, New Delhi  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  Intravenous esmolol  Intravenous esmolol compared to lignocaine and labetalol for attenuation of hemodynamic and stress response to laryngoscopy and endotracheal intubation under general anaesthesia 
Comparator Agent  Intravenous labetalol   Intravenous labetalol compared to lignocaine and esmolol for attenuation of hemodynamic and stress response to laryngoscopy and endotracheal intubation under general anaesthesia 
Comparator Agent  Intravenous lignocaine   Intravenous lignocaine compared to esmolol and labetalol for attenuation of hemodynamic and stress response to laryngoscopy and endotracheal intubation under general anaesthesia  
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA Grade I and II
2. Elective surgical procedure 
 
ExclusionCriteria 
Details  1. Known sensitivity to any drug.
2. Pregnant females.
3. Patient with chronic hypertension and diabetes mellitus.
4. Patient with history of cardiac or respiratory disease.
5. Patient with anticipated difficult airway.
6. Patient with impaired kidney or liver function. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic parameters to laryngoscopy and endotracheal intubation (heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure)  On arrival to OT, on laryngoscopy and intubation at 1 minute, 3 minutes and 5 minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
Biochemical markers of stress response (serum cortisol and blood glucose levels).  At arrival in OT, 5 minutes after endotracheal intubation. 
 
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/ Phase 3 
Date of First Enrollment (India)   11/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/08/2025 
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 Yet Recruiting 
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  

PREANAESTHETIC EVALUATION: 

A detailed pre-anesthetic checkup [PAC] including history, physical examination and 

investigations as guided in accordance with the plan of surgery will be carried out in all patients. 

The procedures will be explained to the patient and informed written consent will be obtained in a 

language that is understood by the patient. The study drug will be administered according to the 

group allocated to the patient. The observer will then collect the data. 


ANAESTHETIC PROCEDURE: 

On arrival in the operating room, standard monitors like pulse oximetry [SpO2], 

electrocardiography[ECG] and non-invasive blood pressure[NIBP] are attached and 

baseline hemodynamic parameters such as heart rate[HR] , systolic blood pressure [SBP], 

diastolic blood pressure[DBP], mean arterial pressure[MAP] will be recorded in supine 

position. 

  Intravenous line will be established by using 18 gauge or 20 gauge cannula and a venous 

sample for Serum Cortisol levels and Blood Glucose will be taken at the same time. 

Intravenous fluids will be started. 

  Based on the allocation of groups, patients will be pretreated with Lignocaine 1.5mg/kg, 

Esmolol 1mg/kg, Labetalol 0.3mg/kg, 5 min prior to Laryngoscopy and oral Endotracheal 

Intubation. Patients will be preoxygenated with 100% oxygen for 3 minutes. Anesthesia 

will be induced with Propofol[2 mg/kg]. Following check ventilation, muscle relaxation 

will be achieved with Vecuronium [0.1mg/kg] intravenously to facilitate Laryngoscopy 

and Endotracheal intubation. 

 After 5 min of administration of study drugs, laryngoscopy and oral endotracheal 

intubation will be performed using cuffed endotracheal tube of appropriate sizes and 

hemodynamic parameters (HR, SBP, DBP, MAP) are recorded. Also on arrival in the 

operating room, at 1 min, 3 min and 5 min following laryngoscopy and endotracheal 

intubation hemodynamic parameters (HR, SBP, DBP, MAP) will be recorded. A venous 

sample will be taken for serum cortisol and blood glucose levels on arrival in the operating 

room and 5 minutes following Laryngoscopy and Endotracheal Intubation at the same time. 

 Anesthesia will be maintained with an inhalational agent and Oxygen: Nitrous Oxide 

[50:50] throughout the surgery and ventilation adjusted to maintain EtCO2 of 30-40 mm 

of Hg throughout the procedure.

 
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