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CTRI Number  CTRI/2025/10/095875 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Attenuation of laryngoscopic response in otorhinolaryngologic surgeries under general anaesthesia. 
Scientific Title of Study   A prospective randomised single-blind observational study to assess the effect of IV dexmedetomidine vs. IV esmolol and lignocaine combination for attenuation of laryngoscopic response in patients undergoing otorhinolaryngologic surgeries 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  Kinal Vyas 
Designation  Resident Doctor 
Affiliation  GMERS medical college and hospital, Gotri, Vadodara 
Address  6th floor, Department of Anaesthesia, GMERS medical college and hospital, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  7016633701  
Fax    
Email  khvyas98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Santosh Dubey 
Designation  Associate Professor 
Affiliation  GMERS medical college and hospital, Gotri, Vadodara 
Address  6th floor, Department of Anaesthesia, GMERS medical college and hospital, Gotri, Vadodara, India

Vadodara
GUJARAT
390021
India 
Phone  9825359853  
Fax    
Email  santosh19692001@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Santosh Dubey 
Designation  Associate Professor 
Affiliation  GMERS medical college and hospital, Gotri, Vadodara 
Address  6th floor, Department of Anaesthesia, GMERS medical college and hospital, Gotri, Vadodara, India

Vadodara
GUJARAT
390021
India 
Phone  9825359853  
Fax    
Email  santosh19692001@yahoo.com  
 
Source of Monetary or Material Support  
GMERS medical college and hospital, Gotri, Vadodara, Gujarat, India-390021 
 
Primary Sponsor  
Name  GMERS medical college and hospital Gotri 
Address  GMERS medical college and hospital, Gotri, Vadodara, Gujarat, India-390021 
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 
Kinal Vyas  GMERS medical college and hospital, Gotri  6th floor, department of anaesthesia, GMERS medical college and hospital, Gotri, Vadodara
Vadodara
GUJARAT 
7016633701

khvyas98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC, GMERS medical college and hospital, Gotri, vadodara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IV dexmedetomidine   comparison of hemodynamic changes will be done while doing laryngoscopy both groups and evaluation of which group is better for attenuating the laryngoscopy response will be compared dose of IV dexmedetomidine -1 mcg per kg 
Comparator Agent  IV esmolol and IV lignocaine  comparison of hemodynamic changes will be done while doing laryngoscopy both groups and evaluation of which group is better for attenuating the laryngoscopy response will be compared dose of IV esmolol and IV lignocaine -0.5 mg per kg and 1.5 mg per kg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  BMI less than 30 kg/m2
ASA 1-2
Pulse rate equal to or above 70/min with regular rhythm  
 
ExclusionCriteria 
Details  Patient Refusal
Allergic to study drugs
On chronic Medication for heart diseases like: AV Blocks, CHF, Brady-arrythmias, IHD, Hypertension.
Laryngoscopy time more than 20 seconds
Difficult bag and mask ventilation
Difficult intubation
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate Hemodynamic response that is pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure & rate pressure product at baseline, 1 minute, 3 minutes & 5 minutes after laryngoscopy   To evaluate pulse rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure & rate pressure product at baseline, 1 minute, 3 minutes and 5 minutes after laryngoscopy  
 
Secondary Outcome  
Outcome  TimePoints 
To note any adverse effects associated with drugs used in both the groups, any rescue medication needed for correction of over-attenuation of the response, such as use of sympathomimetic drugs  To note any adverse effects associated with drugs used in both the groups, any rescue medication needed for correction of over-attenuation of the response, such as use of sympathomimetic drugs till the first 5 minutes of laryngoscopy & intubation 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   14/11/2025 
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="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  

Laryngoscopy and endotracheal intubation are integral components of general anaesthesia for airway management. However, these procedures are associated with intense sympathetic stimulation resulting in a transient but marked increase in heart rate and blood pressure, collectively known as the pressor response or laryngoscopic response. In patients with pre-existing cardiovascular conditions, this response may precipitate myocardial ischemia, arrhythmias, or cerebrovascular events. Hence, attenuating this hemodynamic response is critical for improving perioperative safety and outcomes.

Several pharmacological agents have been studied to mitigate the laryngoscopic response, including opioids, beta-blockers, alpha-2 agonists, calcium channel blockers, and local anaesthetics. Among these, dexmedetomidine, an alpha-2 adrenergic agonist, has gained attention due to its sedative, analgesic, and sympatholytic properties. It has been shown to blunt the stress response effectively while also providing perioperative sedation and analgesia without significant respiratory depression.

Esmolol, a short-acting cardioselective beta-1 adrenergic blocker, is another commonly used agent to suppress the tachycardia and hypertension associated with laryngoscopy. It has a rapid onset and brief duration of action, making it particularly suitable for short-term modulation of hemodynamics during induction and intubation. Lignocaine, a local anaesthetic, when given intravenously, has been used to suppress airway reflexes and blunt the pressor response due to its membrane-stabilizing and antiarrhythmic effects.

While each of these agents—dexmedetomidine, esmolol, and lignocaine—has demonstrated efficacy individually in attenuating the laryngoscopic response, comparative studies are essential to determine the most effective and safe option for clinical practice. The choice of agent may depend on factors such as patient comorbidities, drug onset and duration, side effect profiles, and anaesthetic goals.

Out of all the 3 drugs, dexmedetomidine (>esmolol >lignocaine) is found to be best for decreasing the pressor response, but there are very few studies comparing dexmedetomidine with combination of lignocaine and esmolol for attenuation of laryngoscopic response. So we design this study to ascertain whether attenuation of laryngoscopic response with combination of lignocaine and esmolol is comparable or better than that caused by dexmedetomidine.

The findings may contribute to optimizing anaesthetic management, particularly in patients at risk of hemodynamic instability during airway manipulation.

 
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