| 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
|
|
|
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
|
|
|
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
|
|
|
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. |