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CTRI Number  CTRI/2023/01/049238 [Registered on: 25/01/2023] Trial Registered Prospectively
Last Modified On: 22/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effect of 3 drugs, dexmedetomidine, fentanyl, ketamine in addition to lignocaine nebulization for anesthetizing airway in patients undergoing awake fibreoptic intubation. 
Scientific Title of Study   Comparison of dexmedetomidine, fentanyl, ketamine nebulization as an adjuvant to lignocaine for awake fibreoptic intubation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arya s jith 
Designation  Post graduate student 
Affiliation  YENEPOYA UNIVERSITY 
Address  ARYA.S.JITH,M.Sc.Anaesthesia and operation theatre technology student, Yenepoya school of allied health science, yenepoya [Deemed to be university],Mudipu, Mangalore

Dakshina Kannada
KARNATAKA
574153
India 
Phone  8129164668  
Fax    
Email  aryasuja786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSmita Musti 
Designation  Associate Professor 
Affiliation  Yenepoya Medical College, Mangalore 
Address  Smita Musti Associate Professor Department of Anaesthesia Yenepoya Medical College, Yenepoya (Deemed to be University) Deralakatte Mangalore
S S Musti #2399, Yalakki Oni Haveri 581110
Haveri
KARNATAKA
575018
India 
Phone  9886125842  
Fax    
Email  smitamusti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSmita Musti 
Designation  Associate Professor 
Affiliation  Yenepoya Medical College, Mangalore 
Address  Smita Musti Associate Professor Department of Anaesthesia Yenepoya Medical College, Yenepoya (Deemed to be University) Deralakatte Mangalore
S S Musti #2399, Yalakki Oni Haveri 581110
Haveri
KARNATAKA
575018
India 
Phone  9886125842  
Fax    
Email  smitamusti@gmail.com  
 
Source of Monetary or Material Support  
yenepoya medical college hospital 
 
Primary Sponsor  
Name  Yenepoya medical college hospital 
Address  yenepoya medical college hospital, yenepoya(deemed to be university),Deralakatte,Manglore-575018 
Type of Sponsor  Research institution and hospital 
 
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 Smita Musti  Yenepoya Medical College Hospital  Room no:6,1 Operation theatre complex, 6th floor and 3rd floor, Department of Anaesthesiology, Deralakatte, Dakshina kannada, Mangalore-575018
Dakshina Kannada
KARNATAKA 
9886125842

smitamusti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee 2  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 
Comparator Agent  4% Lignocaine  lignocaine dose-160 mg, Route -inhalational, frequency -single dose, duration -20min. 
Intervention  4% lignocaine with Dexmedetomidine   4% Lignocaine-Dose-160mg, Route-Inhalational route,Duration-20min, Frequency-Single dose. Dexmedetomidine- Dose-1 mcg/kg, Route-Inhalational route, Duration-20 min, Frequency-Single dose.  
Intervention  4% Lignocaine with Fentanyl  4% Lignocaine-160mg Fentanyl-2mcg/kg Fentany-Dose-2mcg/kg, Route-Inhalational route,Duration-20 min, Frequency-Single dose. Ketamine- Dose-2mg/kg, Route-Inhalational route,Duration-20 min, Frequency-Single dose. 
Intervention  4% Lignocaine with Ketamine  4% Lignocaine 160mg+Ketamine- Dose-2mg/kg, Route-Inhalational route,Duration-20 min, Frequency-Single dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients under the category of ASA I/II(American Society of Anaesthesiologist). 
 
ExclusionCriteria 
Details  1.Previous Airway surgery
2.Anticipated difficult airway
3.Nasal Trauma
4.Allergy to Local Anesthetics 
 
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 
1.To determine the cough score.
2.To determine the rate of glottic closure during bronchoscopy and intubation. 
the time from the starting of intubation till the tube reaches the trachea (about 30sec) 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate sedation score.
2.To observe for any other adverse effects. 
the time from the intubation till securing the airway(about 60 sec) 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2023 
Date of Study Completion (India) 31/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
This study is a randomized, double blind, parallel group, single centre trial comparing the effect of dexmedetomidine(1 mcg/kg), fentanyl( 2 mcg/kg), ketamine( 2mg/kg) in addition to 4 % lignocaine (160mg) nebulization during awake fibreoptic intubation. The primary outcome measures will be the cough score and rate of glottic closure at the time from the starting of intubation till the tube reaches the trachea. The secondary outcomes will be sedation score and to observe for other adverse effects.


 
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