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CTRI Number  CTRI/2024/04/066360 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare dexmedetomidine alone versus combination of dexmedetomidine and fentanyl for achieving sedation in awake nasal fibreoptic intubation 
Scientific Title of Study   A randomized comparative study to compare intubation conditions using dexmedetomidine alone versus combination of dexmedetomidine and fentanyl during awake fibre optic intubation in patients undergoing elective Head and Neck cancer surgeries in department of Anaesthesia SMS Medical College and Attached Hospitals Jaipur 
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 Saloni Jain 
Designation  Junior Resident  
Affiliation  SMS Medical College and attached hospitals  
Address  Department of Anaesthesiology, SMS Medical College and attached hospitals, Adarsh Nagar, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9571620603  
Fax    
Email  salonijain1229@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Sharma 
Designation  Senior Professor 
Affiliation  SMS Medical College and attached hospitals  
Address  Department of Anaesthesiology, SMS Medical College and attached hospitals, Adarsh Nagar, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9829566077  
Fax    
Email  drmamtasharma@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saloni Jain 
Designation  Junior Resident  
Affiliation  SMS Medical College and attached hospitals  
Address  Department of Anaesthesiology, SMS Medical College and attached hospitals, Adarsh Nagar, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9571620603  
Fax    
Email  salonijain1229@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, SMS Medical College and attached hospitals, Jaipur  
 
Primary Sponsor  
Name  Dept of Anaesthesiology SMS Medical College Jaipur 
Address  Adarsh Nagar, JLN Marg, Jaipur, Rajasthan, India 302004 
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 Saloni Jain  SMS Medical college and attached hospitals, Jaipur  Surgical oncology OT and ENT OT
Jaipur
RAJASTHAN 		 9571620603

salonijain1229@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS medical college and attached hospitals, Jaipur   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 Fibre optic intubation   To compare intubation conditions using dexmedetomidine alone versus combination of dexmedetomidine and fentanyl infusion for 10 minutes during awake fibre optic intubation in patients undergoing elective head and neck cancer surgeries. 
Comparator Agent  Low dose Dexmedetomidine with fentanyl   To compare intubation conditions using dexmedetomidine alone versus combination of dexmedetomidine and fentanyl infusion for 10 minutes during awake fibre optic intubation in patients undergoing elective head and neck cancer surgeries. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing elective head and neck cancer surgeries where difficult intubation is anticipated due to limited mouth opening (less than two fingers), restriction of neck mobility, lack of space for laryngoscopy, Patients willing to give consent , ASA group I and II 
 
ExclusionCriteria 
Details  Patient included in other studies, non cooperative patient, history of allergy to any study medication, pre existing bleeding and coagulation disorder, patients having bradycardia and heart block, pregnancy, alcohol/drug abuse 
 
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 
Mean Ramsay sedation score, percentage of intubation score, percentage of airway obstruction score, mean intubation Comfort score, percentage post intubation score   Baseline, at end of drug infusion, before starting fibrescopy 
 
Secondary Outcome  
Outcome  TimePoints 
Mean of Haemodynamic parameters (HR,MAP,SpO2), percentage of episodes of desaturation,hypotension,bradycardia. Percentage of ability to recall memory of endoscopy and intubation.  Baseline,at end of drug infusion, before fibrescopy, 1min after intubation, 3 min after intubation. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   06/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
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  

  • Awake fibre‐optic intubation (AFOI) is an integral part of anaesthetic management of difficult airways. Conscious sedation is essential to assist AFOI.


  • Dexmedetomidine, a selective alpha-2 adrenoreceptor agonist, is the agent of choice for many practitioners to achieve sedation in AFOI because of its advantages over the other drugs. It produces profound sedation with easy arousability, without respiratory depression. Furthermore, it has the added advantage of having anxiolytic and analgesic properties. It decreases the salivary secretions, thereby allowing better visualization through the fiberscope.


  • However, at higher doses it can result in cardiovascular depression causing bradycardia and hypotension. These effects are generally temporary and can be successfully treated with atropine or ephedrine and volume infusions


  •  Therefore, we plan to conduct this study to find the optimal and effective lower possible dose of dexmedetomidine in combination with topical spray and local blocks of airway for awake orotracheal fibre-optic intubation

 
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