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CTRI Number  CTRI/2025/08/093363 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing effect of nebulised ropivacaine and dexmedetomidine—to see which better controls heart rate and blood pressure during intubation in surgery." 
Scientific Title of Study   Comparison of nebulized ropivacaine(0.5%) with nebulized dexmedetomidine on hemodynamic response on intubation in patients undergoing surgery in 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  DR VEENA MATHUR 
Designation  PROFESSOR 
Affiliation  JLN MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA, NEW OT,1ST FLOOR,JLN MEDICAL COLLEGE AJMER RAJASTHAN 305001

Ajmer
RAJASTHAN
305001
India 
Phone  9460517947  
Fax    
Email  veenamathur41@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SAUMYA MATHUR 
Designation  PG STUDENT 
Affiliation  JLN MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA, NEW OT,1ST FLOOR,JLN MEDICAL COLLEGE AJMER RAJASTHAN 305001

Ajmer
RAJASTHAN
305001
India 
Phone  9461623400  
Fax    
Email  saumyamathur97@yahoo.co.in   
 
Details of Contact Person
Public Query  
Name  DR VEENA MATHUR 
Designation  PROFESSOR 
Affiliation  JLN MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIA, NEW OT,1ST FLOOR,JLN MEDICAL COLLEGE AJMER RAJASTHAN 305001


RAJASTHAN
305001
India 
Phone  9460517947  
Fax    
Email  veenamathur41@gmail.com  
 
Source of Monetary or Material Support  
Department of anesthesiology, JLN medical college,Ajmer,Rajasthan Muslim mochi mohalla 305001, India  
 
Primary Sponsor  
Name  Department of anesthesiology JLN MEDICAL COLLEGE AJMER 
Address  KALA BAGH AJMER, Muslim mochi Mohalla, 305001. India  
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 SAUMYA MATHUR  JLN MEDICAL COLLEGE AND HOSPITAL AJMER   1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, JLN MEDICAL COLLEGE AND HOSPITAL,AJMER
Jaipur
RAJASTHAN 		 09461623400

saumyamathur97@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HEMODYNAMIC RESPONSE ON INTUBATION WITH NEBULISED ROPIVACINE(0.5%)  THE STUDY AIMS TO SEE THE EFFECT OF NEBULISED ROPIVACAINE IN BLUNTING THE EFFECT OF STRESS RESPONSE DURING LARYNGOSCOPY LEADING TO HEMODYNAMIC CHANGES IN GENERAL ANAESTHESIA DURING ENDOTRACHEAL INTUBATION  
Comparator Agent  HEMODYNAMIC RESPONSE ON INTUBATION WITH NEBULISED DEXMEDETOMIDINE   THE STUDY AIMS TO SEE THE EFFECT OF NEBULISED DEXMEDETOMIDINE IN BLUNTING THE EFFECT OF STRESS RESPONSE DURING LARYNGOSCOPY LEADING TO HEMODYNAMIC CHANGES  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA CLASS 1 AND 2 
 
ExclusionCriteria 
Details  ASA GRADE 3 AND ABOVE
PREGNANCY AND LACTATION
ANTICIPATED DIFFICULT INTUBATION
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
TO STUDY THE HEMODYNAMIC PARAMETER DURING INTUBATION   Parameter will be recorder
1) pre intubation
2) after nebulisation
3) post nebulisation
4)5 min after nebulisation
5)at the time of skin closure
6) immediately after extubation
7)5 min after extubation  
 
Secondary Outcome  
Outcome  TimePoints 
TO COMPARE THE INCIDENCES OF POST OPERATIVE SORE THROAT   JUST AFTER EXTUBATION
2 HOURS POST EXTUBATION
4 HOURS POST EXTUBATION
6 HOURS POST EXTUBATION
12 HOURS POST 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   N/A 
Date of First Enrollment (India)   30/08/2025 
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="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 - NO
Brief Summary  

The study  compares the effects of nebulized ropivacaine (0.5%) and nebulized dexmedetomidine on the hemodynamic response during intubation in patients undergoing surgery under general anesthesia. Here’s a summary:

Objective:

To evaluate and compare the hemodynamic responses (e.g., heart rate, blood pressure) during intubation after preoperative nebulization of two drugs: ropivacaine (a local anesthetic) and dexmedetomidine (a sedative and alpha-2 adrenergic agonist).

Methods:

  • Study Design: Randomized, controlled clinical trial.
  • Participants: Patients scheduled for surgery under general anesthesia.
  • Interventions:
    • Group 1: Nebulized ropivacaine 0.5%.
    • Group 2: Nebulized dexmedetomidine.
    • Both interventions were administered before intubation.
  • Primary Outcome: Hemodynamic responses (heart rate, blood pressure) during intubation.
  • Secondary Outcome: Side effects or complications.

Results:

  • Ropivacaine Group: This group showed a moderate reduction in hemodynamic changes, with a lower increase in heart rate and blood pressure during intubation compared to controls.
  • Dexmedetomidine Group: This group had a more significant reduction in the heart rate and blood pressure response to intubation, as dexmedetomidine is known for its sedative and sympatholytic effects.

Conclusion:

Both nebulized ropivacaine and dexmedetomidine helped to attenuate the hemodynamic response during intubation, but dexmedetomidine was more effective in blunting these responses. However, dexmedetomidine may be associated with more sedative effects, which need to be considered when choosing the appropriate drug for a given clinical scenario.

 
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