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CTRI Number  CTRI/2026/02/102959 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing lidocaine and dexmedetomidine given as nebulisation to reduce changes in heart rate and blood pressure while putting the breathing tube into the windpipe . 
Scientific Title of Study   A comparison of nebulised lidocaine versus dexmedetomidine for attenuation of hemodynamic response to laryngoscopy and tracheal intubation. 
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 Hetalba R Jadeja 
Designation  Resident Doctor Anaesthesiology 
Affiliation  BJ Medical College, Ahmedabad.  
Address  F3,Trauma building, First floor, Department of anaesthesia,Civil hospital campus, Haripura, Asarwa, Ahmedabad.

Ahmadabad
GUJARAT
380016
India 
Phone  9328936627  
Fax    
Email  hjadeja315@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharthkumar B Parmar 
Designation  Associate Professor 
Affiliation  BJ Medical College, Ahmedabad. 
Address  F3,Trauma building, First floor, Department of anaesthesia,Civil hospital campus, Haripura, Asarwa, Ahmedabad.

Ahmadabad
GUJARAT
380016
India 
Phone  9426332701  
Fax    
Email  drsid25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Siddharthkumar B Parmar 
Designation  Associate Professor 
Affiliation  BJ Medical College, Ahmedabad. 
Address  F3,Trauma building, First floor, Department of anaesthesia,Civil hospital campus, Haripura, Asarwa, Ahmedabad.


GUJARAT
380016
India 
Phone  9426332701  
Fax    
Email  drsid25@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  BJ medical college and Civil hospital Ahmedabad 
Address  BJ medical college and Civil hospital , Asarwa, Ahmedabad-380016 
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 Hetalba R Jadeja  Trauma building and 1200 bed hospital, Civil hospital,Asarwa, Ahmedabad  F3,Trauma building, First floor, Department of anaesthesia,Civil hospital campus, Haripura, Asarwa, Ahmedabad.
Ahmadabad
GUJARAT 		 9328936627

hjadeja315@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee,B.J. Medical College and Civil Hospital,Ahmedabad  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  Nebulisation of Dexmedetomidine for attenuation of hemodynamic response to laryngoscopy and tracheal intubation  Administration of nebulised Dexmedetomidine in doses of 1 mcg/kg 15 mins prior to anaesthesia and hemodynamic parameters will be noted. 
Intervention  Nebulisation of Lidocaine for attenuation of hemodynamic response to laryngoscopy and tracheal intubation  Administration of nebulised Lidocaine(2%)in doses of 2mg/kg 15 mins prior to anaesthesia and hemodynamic parameters will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA 1,2,3 undergoing any surgery under general anaesthesia requiring endotracheal intubation
Patients with normal airway anatomy
Non smokers  
 
ExclusionCriteria 
Details  Patients with allergy to study medications
Patients with pregnancy and lactation
Patients with BMI more than 30
ASA 4,5
Patients who will give negative consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare hemodynamic parameters before, during and after laryngoscopy in patients receiving lidocaine nebulisation versus those receiving dexmedetomidine nebulisation  Before and after nebulisation,after pre-medication, before induction, at the time of laryngoscopy, at time of Intubation, on 1st,3rd,5th,10th, 30th minute, 1 hour, 2 hour after laryngoscopy and endotracheal intubation.
 
 
Secondary Outcome  
Outcome  TimePoints 
To study and compare any adverse effect of lidocaine and dexmedetomidine.
 
 		 Till the completion of the surgery 
 
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)   20/02/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 28-02-2027 and end date provided 28-02-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Direct laryngoscopy and tracheal intubation following induction of anaesthesia are associated with hemodynamic changes due to increased sympatho-adrenal activity, which may result in increase in heart rate and blood pressure. This rise in blood pressure and heart rate is transient and variable. This response is likely to be tolerated by healthy patients but can be exaggerated in susceptible individuals and may precipitate hypertensive crises, myocardial ischemia, arrhythmias, or increases in intracranial pressure.

Lidocaine is a local anaesthetic and class 1B antiarrhythmic drug which can provide topical analgesia by blocking nerve conduction and diminish airway reflex. Nebulised Lidocaine(2%)  administered in doses of 2mg/kg is found to be effective to attenuate hemodynamic response after laryngoscopy and tracheal intubation.

Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic and analgesic properties. Nebulised dexmedetomidine administered in doses of 1µg/kg is found to be an effective premedication to attenuate hemodynamic response after laryngoscopy and tracheal intubation.

This study is designed to compare the effect of nebulised Lidocaine versus Dexmedetomidine for attenuation of  hemodynamic response to laryngoscopy and tracheal intubation.




 
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