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CTRI Number  CTRI/2026/03/106001 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 10/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Two Sedation Methods (Dexmedetomidine Alone vs Dexmedetomidine with Ketamine) for Awake Fibre-optic Nasal Intubation 
Scientific Title of Study   A Comparative Study of Intravenous Dexmedetomidine Alone VS Dexmedetomidine Combined With Ketamine To Facilitate Awake Fibreoptic Nasal 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  Urvashi Nautiyal 
Designation  PG Resident 
Affiliation  People College Of Medical Sciences And Research Center 
Address  Room no 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  9685501202  
Fax    
Email  urvi14.nautiyal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Abhilekh Jain 
Designation  Professor Department of Anaesthesiology 
Affiliation  People College Of Medical Sciences And Research Center 
Address  Room no 1 Department of Anaesthesiology Peoples Hospital Bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  9827606268  
Fax    
Email  jainabhilekh@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Urvashi Nautiyal 
Designation  PG Resident 
Affiliation  People College Of Medical Sciences And Research Center 
Address  Room no 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  9685501202  
Fax    
Email  urvi14.nautiyal@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Peoples Hospital Bhopal 
Address  Ayodhya Bypass Road Bhanpur Bhopal Madhya Pradesh 462037 
Type of Sponsor  Private 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 Urvashi Nautiyal  Peoples Hospital  Room No 1 Department of Anaesthesiology Peoples Hospital Bhanpur Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH 		 9685501202

urvi14.nautiyal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Peoples College Of Medical Sciences And Research Centre By Pass Road Bhanpur Bhopal 462037 M P Institutional Ethics Committee  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  Dexmedetomidine  Patient will be given a bolus of Injection Dexmedetomidine 50 micrograms intravenous over 15 minutes before beginning of fiberoptic bronchoscopy. 
Intervention  Dexmedetomidine and Ketamine  Patient will be given a bolus of Injection Dexmedetomidine 50 micrograms intravenous over 15 minutes followed by Injection Ketamine 15 milligram intravenous stat before beginning of fiberoptic bronchoscopy 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients weighing 50-70 kilograms
ASA Grade I and II
All patients undergoing maxillofacial surgeries 
 
ExclusionCriteria 
Details  Patients not giving consent
ASA Grade III and IV
Pregnancy and Lactating mothers
Patient with nasal polyps or masses
Carcinoma of Head and Neck Region and Similar Pathology 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess whether use of dexmedetomidine alone or combined with ketamine provides ease of intubation.  At baseline, two minutes after study drug, at beginning of fiberoptic bronchoscopy, after Endotracheal tube insertion into vocal cords, two minutes after nasal intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To assess whether use of dexmedetomidine alone or combined with ketamine provides better hemodynamic stability to the patient  upto 15 minutes 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   31/03/2026 
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="6"
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   Patients will be divided into two groups, both will receive Injection Dexmedetomidine 50 micrograms, followed by group A will be given a bolus of Injection Ketamine 15 milligram and Group B will receive a bolus of normal saline. Continuous monitoring of vitals will be done at baseline, at two minutes after sedation, at the beginning of fiberoptic bronchoscopy, after Endotracheal tube insertion into vocal cords/cuff is inflated and 2 minutes after nasotracheal intubation.

Scoring system will be used to assess the intubating conditions, vocal cord position, patient comfort and satisfaction during the process of fiberoptic bronchoscopy.




 
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