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CTRI Number  CTRI/2025/03/082745 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 02/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two routes of same drug administered as an additive to a local anaesthetic for Intubation in awake patient using a special device 
Scientific Title of Study   Comparison between Nebulized and Intravenous Dexmedetomidine as an additive to Nebulized Lignocaine for Awake Fiberoptic 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 Shirin Parveen  
Designation  Associate Professor  
Affiliation  Eras Lucknow Medical College and Hospital  
Address  Department of Anaesthesiology Eras Lucknow Medical College and Hospital, Sarfarazganj, Hardoi road, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  7388732089  
Fax    
Email  shirin_grmc@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Kumar 
Designation  Assistant Professor 
Affiliation  Eras Lucknow Medical College and Hospital  
Address  Department of Anaesthesiology Eras Lucknow Medical College and Hospital, Sarfarazganj, Hardoi road, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  8299081739  
Fax    
Email  docraj198810@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bushra Suhail 
Designation  Junior Resident 
Affiliation  Eras Lucknow Medical College and Hospital  
Address  Department of Anaesthesiology Eras Lucknow Medical College and Hospital, Sarfarazganj, Hardoi road, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  8081746376  
Fax    
Email  bushra.ahmad002@gmail.com  
 
Source of Monetary or Material Support  
ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL, SARFARAZGANJ, HARDOI ROAD, LUCKNOW, PIN CODE - 226003, UTTAR PRADESH, INDIA 
 
Primary Sponsor  
Name  Eras Lucknow Medical College and Hospital 
Address  Eras Lucknow Medical College and Hospital, Sarfarazganj, Hardoi road, Lucknow, PIN code - 226003, Uttar Pradesh, India. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Bushra Suhail  Department of Anaesthesiology Eras Lucknow Medical College and Hospital, Sarfarazganj, Hardoi road, Lucknow  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bushra Suhail  ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL  Department of Anaesthesiology, 1st floor, ELMCH, Sarfarazganj, Hardoi road, Lucknow, PIN code - 226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 8081746376

bushra.ahmad002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Eras Lucknow Medical College & Hospital, Era University, Lucknow  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  Awake Fiberoptic Intubation  A technique which allows a flexible oral or nasal route to provide a clear vsualisation of the vocal cords, and subsequent passage of an endotracheal tube into the trachea under direct vision (using a flexible endoscope with camera) in awake patients Using this technique we are doing the study 
Comparator Agent  Comparison between Nebulized and Intravenous Dexmedetomidine as an additive to Nebulized Lignocaine for Awake Fiberoptic Intubation   To compare two routes of same drug , nebulized Dexmedetomidine and intravenous Dexmedetomidine as an additive to nebulized Lignocaine (local anaesthetic) during awake fiberoptic intubation (intubation in awake patients using a fiberoptic device) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients belonging to American Society of Anaesthesiologists physical status I or II.
Patients scheduled to undergo elective surgery under general anaesthesia.
Patients with predicted difficult airway (defined as mouth opening less than 3 cm or thyromental distance less than 6.5 cm or sternomental distance less than 12.5 cm or modified Mallampati class III/IV, or limited neck movements).
 
 
ExclusionCriteria 
Details  Patients with known or suspected allergy to Dexmedetomidine or Lignocaine.

Patients with thrombocytopenia or bleeding diathesis.

Patients with psychiatric disorder or uncooperative patients.

HR less than 50 bpm.

Second or third degree heart block.

Pregnancy and lactation.
 
 
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 assess the total duration required for awake fiberoptic intubation.

 		 Less than 15 mins 
 
Secondary Outcome  
Outcome  TimePoints 
1 To assess the patient comfort and tolerance during intubation using patient tolerance score (PTS).
2 To assess the degree of sedation using Ramsay sedation score (RSS).
3 To assess the intensity of cough during the procedure using cough score.
4 To assess the variations in heart rate (HR), mean arterial pressure (MAP), Oxygen saturation (SPO2) at different time intervals.
 		 At the time of intubation
5 mins after intubation and 10 mins after intubation  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   30/04/2025 
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="2"
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
    Response - Informed Consent Form

  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 [bushra.ahmad002@gmail.com].

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 05-09-2026?
    Response - Immediately following publication. No end date.

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