FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094842 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparing the effect of nebulized dexmedetomidine with lignocaine vs lignocaine alone for patients undergoing awake fibreoptic intubation 
Scientific Title of Study   Comparative evaluation of the efficacy of Nebulized Dexmedetomidine as an additive to Nebulized lignocaine for difficult awake fibreoptic Intubation 
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 Priya Motiani 
Designation  Senior Consultant and Academic Coordinator Department of Anesthesia 
Affiliation  Fortis Hospitals Limited 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA
560076
India 
Phone  9342203747  
Fax    
Email  cl.researchfhbg2@fortishealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priya Motiani 
Designation  Senior Consultant and Academic Coordinator Department of Anesthesia 
Affiliation  Fortis Hospitals Limited 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA
560076
India 
Phone  9342203747  
Fax    
Email  motianidrpriya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priya Motiani 
Designation  Senior Consultant and Academic Coordinator Department of Anesthesia 
Affiliation  Fortis Hospitals Limited 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore

KARNATAKA
560076
India 
Phone  9342203747  
Fax    
Email  motianidrpriya@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Academic Investigator Initiated Project 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore 
Type of Sponsor  Private hospital/clinic 
 
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 Priya Motiani  Fortis Hospitals Limited  Department of Anesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA 
9342203747

motianidrpriya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Fortis Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  lignocaine nebulization   Nebulize 3ml of 4% lignocaine 128 mg (total 6ml)  
Intervention  nebulized dexmedetomidine   Nebulize 1 µg/kg dexmedetomidine with 3ml of 4% lignocaine 128 mg (total 6ml)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged 18 years and above
patients belonging to ASA category 1,2 and 3
undergoing elective surgery requiring awake fibreoptic orotracheal intubation as a part of general anaesthesia
willing to participate and provide informed consent
 
 
ExclusionCriteria 
Details  Known allergy to dexmedetomidine or lignocaine
Severe cardiovascular, hepatic or renal disease
Sinus bradycardia or heart block
Pregnancy or lactation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy and safety of nebulized dexmedetomidine as an additive to nebulized lignocaine with respect to cough and gag reflex  At the end of study duration data will be collected study duration 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic stability, glottis closure, patient satisfaction scores, sedation level and incidence of adverse drug reactions like bradycardia or hypotension.  At the end of study duration data will be collected study duration 12 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   26/09/2025 
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  

Since the 1960s, awake fibreoptic intubation (AFOI) has been established as the gold standard for anticipated difficult tracheal intubation. AFOI usually requires good sedation, patient cooperation, and preserved spontaneous respiration. The conscious sedation is desirable to make this procedure more tolerable. Adequate airway preparation is essential to minimize patient discomfort, to optimize intubating conditions, and to ensure procedural success. This can be achieved in broadly two ways- topical administration of local anaesthetic and blockade of neural supply to oropharynx and larynx. Topical administration of local anaesthetic in the form of spray or gargle causes less discomfort and trauma to patients as compared to airway nerve blocks. Topical application by nebulization technique is one of the promising techniques used to anesthetize the airway. Various pharmacological methods have been reported to achieve conscious sedation for AFOI including fentanyl, midazolam, ketamine, propofol, remifentanil and dexmedetomidine.

The combination of moderate conscious sedation and regional anaesthesia has been more commonly used to relieve patient anxiety and to suppress the pharyngeal, laryngeal, tracheal, and bronchial reflexes during AFOI. Effect of lignocaine nebulization has been studied extensively.

 

 Dexmedetomidine is a highly selective and specific alpha 2 adrenoreceptor agonist and has properties making it suitable for AFOI. In addition to hemodynamic stability, anxiolytic and analgesic properties, it results in sedation while maintaining easy reusability, it also causes relaxation of bronchial smooth muscles thus reduces cough reflex and inhibits the salivary gland secretions. Dexmedetomidine demonstrates minimal respiratory depression.

 

Nebulized dexmedetomidine administration allows rapid absorption through nasal, respiratory and buccal mucosa. The bioavailability is 65% through nasal mucosa and 82% through buccal mucosa.

 

 
Close