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CTRI Number  CTRI/2025/06/089333 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 21/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison between lignocaine nebulization with and without dexmedetomidine in patients undergoing awake fiberoptic intubation following airway block 
Scientific Title of Study   Comparative study between lignocaine nebulization with and without dexmedetomidine in patients undergoing awake fiberoptic intubation following airway block : a randomized 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  Anwesha Mandal  
Designation  Post Graduate Trainee 
Affiliation  IPGMER and SSKM Hospital 
Address  IPGMER and SSKM Hospital Department of Anaesthesiology,3rd Floor, Main block,244 AJC Bose Road Kolkata West Bengal 700020

Kolkata
WEST BENGAL
700020
India 
Phone  8016510275  
Fax    
Email  anwesha951@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anwesha Mandal  
Designation  Post Graduate Trainee 
Affiliation  IPGMER and SSKM Hospital 
Address  IPGMER and SSKM Hospital Department of Anaesthesiology,3rd Floor, Main block,244 AJC Bose Road Kolkata West Bengal 700020

Kolkata
WEST BENGAL
700020
India 
Phone  8016510275  
Fax    
Email  anwesha951@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arpita Laha 
Designation  Professor Head of Department  
Affiliation  IPGMER and SSKM Hospital 
Address  IPGMER and SSKM Hospital Department of Anaesthesiology 3rd Floor, Main block 244 AJC Bose Road Kolkata West Bengal 700020

Kolkata
WEST BENGAL
700020
India 
Phone  9433326667  
Fax    
Email  arpitalaha2@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology IPGMER and SSKM Hospital Bhowanipore Kolkata West Bengal 700020 
 
Primary Sponsor  
Name  Department of Anaesthesiology  
Address  IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata West Bengal 700020 
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 Anwesha Mandal  IPGMER and SSKM Hospital  Department of Anaesthesiology, 3rd Floor ,Main Block,244 AJC Bose Road,Kolkata 700020 Bhowanipore kolkata West Bengal
Kolkata
WEST BENGAL 		 8016510275

anwesha951@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Research Oversight 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  Lignocaine  To determine time for intubation using 2% lignocaine nebulization for patients undergoing awake fiberoptic intubation following airway block 
Intervention  Lignocaine with dexmedetomidine   To determine time for intubation using 2 mcg/kg dexmedetomidine with lignocaine 2% nebulization for patients undergoing awake fiberoptic intubation following airway block  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients that have given written, informed consent to participate the study, American Society of Anaesthesiologist physical status 1 , patients undergoing surgery under general anaesthesia 
 
ExclusionCriteria 
Details  Refusal to participate study, Allergy to local anaesthetics or any of the study drugs, pregnant and lactation, contraindication to regional nerve block like bleeding disorder and infection at the site of block, emergency operation 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Intubation time after adding dexmedetomidine with lignocaine nebulization as additive to airway block during awake fiberoptic intubation  At the time from passing the fiberoptic endoscope tip through the nostril to the first reading obtained by the capnograph after endotracheal intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Cough severity score, Intubating condition, Patient comfort score, Hemodynamic changes and Complications if any  16 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2 
Date of First Enrollment (India)   10/07/2025 
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="4"
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   This study is a randomized , double-blinded trial comparing lignocaine nebulization with and without dexmedetomidine in patients undergoing awake fiberoptic intubation in IPGME&R ,Kolkata.The primary outcome measures intubation time .Secondary outcomes measures cough severity score, Intubating condition, Patient comfort score, Hemodynamic changes and complications if any. 
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