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CTRI Number  CTRI/2024/06/068262 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   This is a study to Compare how well nebulization with lignocaine alone and lignocaine with dexmedetomidine works for patients going for awake nasal intubation using a fiber optic scope. 
Scientific Title of Study   Comparison of effectiveness of nebulization with lignocaine alone or with dexmedetomidine in patients undergoing awake nasotracheal intubation under fiber optic guidance. 
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 Renu Bala 
Designation  Professor 
Affiliation  Pt. B D Sharma, PGIMS, Rohtak 
Address  Department of Anaesthesiology & Critical Care, 2nd floor Modular OT complex Pt. B D Sharma, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  8901322251  
Fax    
Email  neurodmrenu@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jitendra Kumar 
Designation  Junior resident 
Affiliation  Pt. B D Sharma, PGIMS, Rohtak 
Address  Department of Anaesthesiology & Critical Care, 2nd floor Modular OT complex Pt. B D Sharma, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  7210373666  
Fax    
Email  jitendrakr99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jitendra Kumar 
Designation  Junior resident 
Affiliation  Pt. B D Sharma, PGIMS, Rohtak 
Address  Department of Anaesthesiology & Critical Care, 2nd floor Modular OT complex Pt. B D Sharma, PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  7210373666  
Fax    
Email  jitendrakr99@gmail.com  
 
Source of Monetary or Material Support  
Pt. B.D. Sharma PGIMS, Rohtak, 124001 Haryana India 
 
Primary Sponsor  
Name  Institute Department of Anaesthesiology and Critical care PGIMS ROHTAK 
Address  Department of Anaesthesiology And Critical Care 2nd floor Modular OT complex Pt B D Sharma PGIMS Rohtak Haryana 124001 India  
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 Jitendra Kumar  Pt. B D Sharma, PGIMS, Rohtak   Department of Anaesthesiology & Critical Care, 2nd floor Modular OT complex Pt. B D Sharma, PGIMS, Rohtak
Rohtak
HARYANA 
7210373666

jitendrakr99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committiee pt. B. D. Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1 Lignocaine 2 Dexmedetomidine  Group with Lignocaine nebulization alone, drug will be prepare with 5ml of 4% Lignocaine to which 1ml Normal saline will be added. Total drug volume will be 6 ml. In another drug group dexmedetomidine 100mcg/ml will be taken in insulin syringe and 1mcg/kg will be added to 5ml of 4% Lignocaine and further diluted with normal saline to make total drug volume of 6 ml. After 20mins of nebulization effect of local anaesthetics will be confirmed by heaviness of tongue and hoarseness of voice 
Intervention  Comparison of effectiveness of drugs for nasotracheal intubation under fiber optic guidance  Comparison of effectiveness of nebulization with lignocaine alone or with dexmedetomidine in patients undergoing awake nasotracheal intubation under fiber optic guidance. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  A total of 50 patients, age group 18-60 years, either gender, belonging to ASA physical status I, II having anticipated difficult airways schedule to undergo elective surgery under general anaesthesia and requiring endotracheal intubation will be enrolled. 
 
ExclusionCriteria 
Details  Refusal to participation, non-cooperative patient, Psychiatric conditions, Allergic to study drugs, Bradycardia and hypotension, Nasal pathology, Coagulation abnormalities, Intracranial hypertension & glaucoma, 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 
Time required for intubation  At the baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
Success rate,
Number of attempts taken,
Ease of intubation as per intubation difficulty score (IDS)
 
At the baseline. 
 
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   Phase 2 
Date of First Enrollment (India)   15/06/2024 
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  

Airway management has significantly improved, but difficult airways remain a major challenge for anesthetists, causing 25% of anesthesia-related deaths. When a difficult airway is expected, securing the airway while the patient is awake is the safest approach. Fiberoptic bronchoscopy, introduced in 1967, is the gold standard for managing difficult airways, with a success rate of 88%-100%. It allows direct guidance and can be performed while the patient is awake, maintaining oxygenation. Effective airway anesthesia is essential and can be achieved using local anesthetics through various techniques, such as sprays, gargles, and nebulization, or by blocking specific nerves. Nebulization is simple, non-invasive, and effective for awake fiberoptic intubations, though it might need supplementation with nerve blocks or the spray-as-you-go (SAYGO) technique. Dexmedetomidine, an α2 adrenoreceptor agonist, provides sedation without significant respiratory depression and reduces salivary secretions, making it suitable for awake fiberoptic intubation. It has anxiolytic, hypnotic, analgesic, amnesic, and antisialogogue properties. Nebulized dexmedetomidine, combined with lidocaine, has been effective for awake videoendoscopic intubations, reducing coughing and recovery time. This study aims to evaluate the effectiveness of adding dexmedetomidine to lignocaine nebulization for awake fiberoptic nasotracheal intubation in patients with predicted difficult airways, as current literature lacks sufficient evidence-based recommendations.

 
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