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CTRI Number  CTRI/2022/07/044029 [Registered on: 14/07/2022] Trial Registered Prospectively
Last Modified On: 02/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   comparison of ropivacaine (a local anesthetic) and dexmedetomidine when given through nebulisation (steam vapours) on the heart rate and blood pressure during start of surgery under general anesthesia 
Scientific Title of Study   Comparison of nebulised ropivacaine 0.75%, nebulised dexmedetomidine on hemodynamic response on intubation in patients undergoing surgery under general anaesthesia : A comparative double blind placebo controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravneet Kaur Gill 
Designation  Assistant Professor 
Affiliation  Dr B R Ambedkar State Institute of Medical Sciences 
Address  Dr B R Ambedkar State Institute of Medical Sciences, Department of Anaesthesia Sector 56, Mohali

Rupnagar
PUNJAB
160055
India 
Phone  9501988361  
Fax    
Email  drravneetkgill@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravneet Kaur Gill 
Designation  Assistant Professor 
Affiliation  Dr B R Ambedkar State Institute of Medical Sciences 
Address  Dr B R Ambedkar State Institute of Medical Sciences, Department of Anaesthesia Sector 56, Mohali


PUNJAB
160055
India 
Phone  9501988361  
Fax    
Email  drravneetkgill@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravneet Kaur Gill 
Designation  Assistant Professor 
Affiliation  Dr B R Ambedkar State Institute of Medical Sciences 
Address  Dr B R Ambedkar State Institute of Medical Sciences, Department of Anaesthesia Sector 56, Mohali


PUNJAB
160055
India 
Phone  9501988361  
Fax    
Email  drravneetkgill@gmail.com  
 
Source of Monetary or Material Support  
Dr B R Ambedkar State Institute of Medical Sciences sector 56, Mohali 
 
Primary Sponsor  
Name  Dr B R Ambedkar State Institute of Medical Sciences 
Address  Sector 56 , Mohali 
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 Ravneet Kaur Gill  Dr B R Ambedkar State Institute of Medical Sciences  Main OT complex, First floor , Department of Anaesthesia
Rupnagar
PUNJAB 		 9501988361

drravneetkgill@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  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  Control (Normal saline)  will receive ultrasonic nebulisation with normal saline. (5 ml) for 10 minutes 
Comparator Agent  Dexmedetomidine  Patients will receive ultrasonic nebulisation with dexmedetomidine 1 µg/kg with 3-4 ml saline. (Total volume 5 ml) for 10 minutes 
Intervention  Ropivacaine  Patients will receive ultrasonic nebulisation with 0.75% ropivacaine (5 ml) for 10 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.American Society of Anesthesiologists (ASA) physical status I - II
2.Age – 18-60 years
3. Scheduled to undergo elective surgery of duration < 2 hours under general anaesthesia   
 
ExclusionCriteria 
Details  1.Patient with pre operative sore throat or upper respiratory tract infection
2.Patients with history of allergy to local anesthestics
3.Patents with history of allergy to Dexmedetomidine
4.Patients with history of cardiac, liver or renal disorders.
5. Patient with anticipated difficult airway with anticipated duration of laryngoscopy > 15 seconds
6. patients who refuse to participate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the hemodynamic response of nebulised ropivacaine 0.75% with nebulised dexmedetomidine and with saline during intubation in patients undergoing surgery under general anesthesia.   before and after nebulisation, before intubation, at the time of intubation and 5 minutes after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic parameters at extubation.
 		 at time of extubation, 5 minutes after extubation 
To compare cough response after extubation  0 ,5 and 30 minutes  
to assess for post operative sore throat  0,2,4,6,12,24 hours 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="165" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2022 
Date of Study Completion (India) 14/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 - Proposals should be directed to [drravneetkgill@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Sympathetic stimulation due to laryngoscopy and endotracheal intubation results in hemodynamic fluctuations both at intubation as well as extubation. This unwanted hemodynamic response may have deleterious effects in some patients. Various methods are employed for suppression of hemodynamic pressor response at intubation eg iv opioids, alpha agonists, lignocaine etc but at the expense of systemic effects. We will use long acting local anaesthetic ropivacaine 0.75% and alpha agonist dexmedetomidine through ultrasonic nebulisation for direct local action of the drug in the airway. 

Total 180 patients will be enrolled for this randomised double blinded placebo controlled study.

The primary objective of the study will be to compare the hemodynamic response of nebulised ropivacaine 0.75% with nebulised dexmedetomidine and with saline during intubation in patients undergoing surgery under general anesthesia. hemodynamic response at extubation , cough response grading and post operative sore throat will also be observed.

 
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