| CTRI Number |
CTRI/2025/12/098795 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two types of inhaled calming and numbing medicines to help patients stay comfortable during a breathing tube placement while they remain awake during surgeries |
|
Scientific Title of Study
|
Comparison Of Nebulized Dexmedetomidine Plus Lidocaine Combination Versus Nebulized Dexmedetomidine Alone For Awake Fiberoptic Nasotracheal Intubation A Prospective Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradipta Laha |
| Designation |
Junior Resident Anaesthesia |
| Affiliation |
Command Hospital Eastern Command |
| Address |
Command Hospital Eastern Command
Alipore Kolkata
Department Anaesthesia
Second Floor
Pre Operative Room One
Kolkata
WEST BENGAL
700027
India |
| Phone |
8158036188 |
| Fax |
|
| Email |
babai.pradipta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Col Dr Kunal Sarin |
| Designation |
Associate Professor MBBS MD Anaesthesiology |
| Affiliation |
Command Hospital Eastern Command |
| Address |
Command Hospital Eastern Command
Alipore Kolkata
Department Anaesthesia
Second Floor
Pre Operative Room One
Kolkata
WEST BENGAL
700027
India |
| Phone |
8283923606 |
| Fax |
|
| Email |
dr.kunal.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Col Dr Kunal Sarin |
| Designation |
Associate Professor MBBS MD Anaesthesiology |
| Affiliation |
Command Hospital Eastern Command |
| Address |
Command Hospital Eastern Command
Alipore Kolkata
Department Anaesthesia
Second Floor
Pre Operative Room One
Kolkata
WEST BENGAL
700027
India |
| Phone |
8283923606 |
| Fax |
|
| Email |
dr.kunal.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Eastern Command
Alipore Kolkata India West Bengal India 700027 |
|
|
Primary Sponsor
|
| Name |
Pradipta Laha |
| Address |
Command Hospital Eastern Command
Alipore Road Alipore Kolkata 700027 |
| Type of Sponsor |
Other [Self] |
|
|
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 Pradipta Laha |
Command Hospital |
Command Hospital Eastern Command
Alipore Kolkata
Department Anaesthesia
Second Floor
Pre Operative Room One
Kolkata
WEST BENGAL |
8158036188
babai.pradipta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital eastern command |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To Compare Effect Of Nebulized Dexmedetomidine plus Lidocaine Versus Dexmedetomidine Alone During Awake Fiberoptic Nasotracheal Intubation |
Total 88 Patients Will Be Enrolled For AFOI. They will Be Divided Into Two Groups 44 in Each Group. Nebulised dexmedetomidine 2 mcg/kg alone, delivered over 10 minutes using a standard jet nebuliser. A Fiberoptic Bronchoscope Will Be Used For Nasotracheal Intubation by An Anesthesiologist. Group DN will be the comparator agent |
| Intervention |
To Compare Effect Of Nebulized Dexmedetomidine plus Lidocaine Versus Dexmedetomidine Alone During Awake Fiberoptic Nasotracheal Intubation |
Total 88 Patients Will Be Enrolled For AFOI. They will Be Divided Into Two Groups 44 in Each Group.Intranasal dexmedetomidine (2 mcg/kg) combined with intranasal lignocaine (1 mg/kg), administered 20 minutes prior to awake nasal fibreoptic intubation.This is the intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I-II
Schedule For Elective Surgery Under General Anaesthesia With AFOI
Informed Written Consent |
|
| ExclusionCriteria |
| Details |
Patient Unwilling To Participate
Nasal Obstruction Polyps Bleeding Disorders
Allergy To Lidocaine Or Dexmedetomidine
Pregnant Women |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Time Required For Awake Fiberoptic Nasotracheal Intubation Between The Two Groups |
Time from Insertion Of Fiber Optic Probe Till Appearance of Etco2 Capnography on the monitor will be recorded |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease & Quality of Awake Fiberoptic Nasotracheal Intubation
Hemodynamic Stability During Awake Fiberoptic Nasotracheal Intubation
Incidence OF Complications like Fall in Spo2 , Bleeding, Vomiting
|
Assessment will be done at
Baseline pre drug
At the start of procedure
Five minutes post intubation
Ten minutes post intubation |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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 Yet Recruiting |
| 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 Prospective Randomized controlled study is the comparison of nebulized dexmedetomidine plus lidocaine versus dexmedetomidine alone in awake nasotracheal fiberoptic intubation. The place of study is Command Hospital Eastern Command a tertiary care teaching hospital in Kolkata . The total duration of the study is 16 months. Total Number of participants in the study is 88. The inclusion criteria of the study are age between 18 to 65 years with ASA physical status I to II who are scheduled for elective surgery under general anaesthesia. The participants will be divided into two groups 44 in each. Group DL will receive nebulized dexmedetomidine combined with lidocaine and group DN will receive nebulized dexmedetomidine with normal saline which will be administered 20 minutes prior to awake fiberoptic intubation. Premedication will be given in both the groups. The primary objective is to compare the time required for awake fiberoptic nasotracheal intubation between the two groups. The secondary objectives of this study is to assess the ease and quality of awake fiberoptic nasotracheal intubation. This study aims to evaluate whether the addition of nebulized lidocaine improves the outcome compared to nebulized dexmedetomidine alone during awake fiberoptic nasotracheal intubation. The study is a double blinded study where the participants and professional performing the procedure will be blinded. Randomization will be done by sealed opaque envelopes. |