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CTRI Number  CTRI/2022/03/041006 [Registered on: 11/03/2022] Trial Registered Prospectively
Last Modified On: 05/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison between two drugs- dexmedetomidine and lidocaine, when administered via two routes- nebulized and intravenous as a premedication for awake fibreoptic intubation in attenuating the haemodynamic changes and for patient comfort 
Scientific Title of Study   Comparison between nebulized dexmedetomidine- lidocaine mixture and intravenous dexmedetomidine- lidocaine nebulization as a premedication for awake fibreoptic intubation.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Reshma Jose 
Designation  DNB Anaesthesiology Resident 
Affiliation  Narayana Hrudayalaya Hospital 
Address  Narayana Hrudayalaya Hospital 258/A Bommasandra Industrial Area Anekal Taluk Bangalore
Palamkunnel (H) Nediyasala P.O Thodupuzha Idukki Kerala PIN 685608
Bangalore
KARNATAKA
560099
India 
Phone  9742581820  
Fax    
Email  reshmajose010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naveena Kadli 
Designation  Senior Consultant 
Affiliation  Narayana Hrudayalaya Hospital 
Address  Department of Anaesthesiology Narayana Hrudayalaya Hospital 258/A Bommasandra Industrial Area Anekal Taluk Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  7406396276  
Fax    
Email  kadlinaveena@gmail.com  
 
Details of Contact Person
Public Query  
Name  Reshma Jose 
Designation  DNB Anaesthesiology Resident 
Affiliation  Narayana Hrudayalaya Hospital 
Address  Narayana Hrudayalaya Hospital 258/A Bommasandra Industrial Area Anekal Taluk Bangalore
Palamkunnel (H) Nediyasala P.O Thodupuzha Idukki Kerala PIN 685608
Bangalore
KARNATAKA
560099
India 
Phone  9742581820  
Fax    
Email  reshmajose010@gmail.com  
 
Source of Monetary or Material Support  
Mazumdar Shaw Medical Centre, Narayana Hrudayalaya Hospital, Bangalore 
 
Primary Sponsor  
Name  Reshma Jose 
Address  DNB Anaesthesiology Resident Narayana Hrudayalaya Hospital 258/A Bommasandra Industrial Area Anekal Taluk Bangalore 
Type of Sponsor  Other [Self] 
 
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 
Reshma Jose  Mazumdar Shaw Medical Centre, Narayana Hrudayalaya Hospital  DNB Anaesthesiology Resident Department of Anaesthesiology Bommasandra Industrial Area Anekal Taluk Bangalore
Bangalore
KARNATAKA 		 9742581820

reshmajose010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academics  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Prospective double blind study Intravenous dexmedetomidine- nebulized lidocaine group  Nebulization of 3 ml 4% lignocaine along with intravenous dexmedetomidine at the dose of 1 mcg/kg/min for 10 minutes 
Intervention  Prospective double blind study Nebulized dexmedetomidine - lidocaine group  Nebulization of 3ml 4% lignocaine along with nebulization of dexmedetomidine at 1 mcg/kg till it gets over 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 patients between 18 to 65 years planned for elective fibreoptic intubation in head and neck surgeries in Mazumdar Shaw Medical Centre, Bangalore 
 
ExclusionCriteria 
Details  Patient refusal
Pregnancy
Known cardiac diseases including heart block
Intracranial pathology and cerebrovascular diseases 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of patient comfort in terms of cough score  10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of bradycardia and hypotension  10 minutes 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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   Phase 4 
Date of First Enrollment (India)   01/04/2022 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 -  Study Protocol
    Response - Clinical Study Report

  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 - Proposals should be directed to [reshmajose010@gmail.com].

  6. For how long will this data be available start date provided 30-08-2022 and end date provided 30-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This is a prospective, double blind study to compare the efficiency of nebulized dexmedetomidine - lidocaine mixture and intravenous dexmedetomidine - lidocaine nebulization as a premedication for awake fibreoptic intubation in head and neck surgeries in Mazumdar Shaw Medical Centre, Bangalore. The primary objective is to measure the patient comfort in terms of cough score. The secondary outcome will be the comparison of incidence of bradycardia and hypotension in between the two study groups.  
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