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CTRI Number  CTRI/2024/07/071064 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of nebulisation with three drugs , dexmedetomidine , ketamine and lidocaine on suppression of gag reflex in patients undergoing transesophageal echo . 
Scientific Title of Study   Nebulisation with dexmedetomidine vs ketamine vs lignocaine for the ease of insertion of transesophgeal echo probe in adults in terms of suppression of gag reflex a randomised controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rituraj charan 
Designation  Post graduate student  
Affiliation  Dr S.N.Medical college , jodhpur 
Address  Room no 11 Cardiology department MDM Hospital Jodhpur
MDM Hospital Jodhpur
Jodhpur
RAJASTHAN
342006
India 
Phone  9461340799  
Fax    
Email  riturajcharan22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh karnawat 
Designation  Senior professor 
Affiliation  Dr Sampurnanand medical college  
Address  Cardiothoracic OT MDM Hospital Jodhpur
Cardiothoracic OT MDM hospital Dr SNMC Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone  9828033321  
Fax    
Email  dr.rakeshkarnawat@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh karnawat 
Designation  Senior professor 
Affiliation  Dr Sampurnanand medical college  
Address  Cardiothoracic OT MDM Hospital Jodhpur
Cardiothoracic OT MDM Hospital Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone  9828033321  
Fax    
Email  dr.rakeshkarnawat@yahoo.com  
 
Source of Monetary or Material Support  
MDM Hospital Dr SN Medical College jodhpur India Pin Code : 342006 
 
Primary Sponsor  
Name  DR Sampurnanand Medical college 
Address  Dr Sampurnanand medical college Shashtri Nagar Jodhpur India 342006 
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 Rituraj charan  Mathura Das Mathur Hospital   Room no 11 Echo room Department of cardiology MDM hospital Jodhpur India 342006
Jodhpur
RAJASTHAN 		 9461340799

riturajcharan22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , DR SAMPURNANAND MEDICAL COLLEGE , JODHPUR  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 
Intervention  Group Dexmedetomidine   Patients receive nebulisation with Dexmedetomidine 1mcg/kg in 3-4 mL NS for 15 mins  
Comparator Agent  Group ketamine   Patients receiving nebulisation with ketamine 50 mg in 4 mL NS for 15 mins 
Comparator Agent  Group lidocaine   Patients nebulised with lidocaine 4% 2.5 ml in 3-4 ml NS for 15 minutes  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults patients between 21 to 65 years of either genders, who are planned for trans echocardiography 
 
ExclusionCriteria 
Details  1. Patients with known allergies to above drugs
2. Patients who are already intubated or have any speech disability or know intellectual disorder leading to communication difficulties
3 . Patients with sick sinus syndrome 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the severity of gag reflex on Dickinson and fiske gagging severity scale   At the time of probe insertion ; 5 minutes ;15 minutes;30minutes ;45 minutes; at end of procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Total time taken for probe insertion
Total Time of procedure
Total remifentanyl consumption  		 Total time taken for probe insertion in minutes
Total time of procedure in minutes to hours
Hemodynamic parameters at 0 min , 5 mins, 15 mins , 30 mins, 45 mins ,at end of procedure  
 
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)   15/08/2024 
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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [riturajcharan22@gmail.com].

  6. For how long will this data be available start date provided 25-11-2025 and end date provided 25-11-2030?
    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   The study compares the ease of insertion of transesophageal echo probe in terms of suppression of gag reflex in three different groups nebulised with dexmedetomidine vs ketamine vs lidocaine . 
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