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CTRI Number  CTRI/2025/11/096818 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 02/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparative study of three medicines Dexmedetomidine, Fentanyl and Ketamine for comfort and safety during awake fiberoptic intubation. 
Scientific Title of Study   A randomised controlled double-blinded study comparing intubation conditions, patient comfort, and hemodynamic stability with Dexmedetomidine, Fentanyl, and Ketamine when combined with Midazolam during awake fiberoptic 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  Dr Lovejeet Rathee 
Designation  Resident Anesthesiology 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9991118922  
Fax    
Email  lovejeetrathee13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra Solanki 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9414131931  
Fax    
Email  dr.rajendrasolanki51@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra Solanki 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  Department Of Anesthesiology and Critical Care, Third Floor Pacific Medical College and Hospital, Bilo ka Bedla Udaipur Rajasthan Udaipur


RAJASTHAN
313001
India 
Phone  9414131931  
Fax    
Email  dr.rajendrasolanki51@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care,Third Floor Main Campus , Pacific Medical College and Hospital Udaipur Rajasthan Pin Code 313001 
 
Primary Sponsor  
Name  PACIFIC MEDICAL COLLEGE AND HOSPITAL UDAIPUR 
Address  Department of Anaesthesiology and Critical care, Pacific Medical College and Hopsital,Third Floor Bilo Ka bedla ,Udaipur Rajasthan Pin Code 313001 
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 Lovejeet Rathee  Pacific Medical college and Hospital  Pacific Medical college and Hospital,Department of Anaesthesiology and Critical care,Third Floor,Bilo ka bedla Udaipur RAJASTHAN
Udaipur
RAJASTHAN 		 9991118922

lovejeetrathee13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee Pacific Medical College And Hospital Udaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z018||Encounter for other specified special examinations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Dexmedetomidine 1 µg/kg intravenous infusion over 10 minutes, given 10 minutes before awake fiberoptic intubation, combined with Midazolam 0.02 mg/kg IV bolus. Airway topicalization with 4% lignocaine and oxygen via nasal cannula provided to all patients. 
Comparator Agent  Fentanyl  Fentanyl 2 µg/kg intravenous bolus, given 10 minutes before awake fiberoptic intubation, combined with Midazolam 0.02 mg/kg IV bolus. Airway topicalization with 4% lignocaine and oxygen via nasal cannula provided to all patients. 
Comparator Agent  Ketamine  Ketamine 0.5 mg/kg intravenous bolus, given 10 minutes before awake fiberoptic intubation, combined with Midazolam 0.02 mg/kg IV bolus. Airway topicalization with 4% lignocaine and oxygen via nasal cannula provided to all patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 65 requiring awake fibreoptic intubation.
ASA Physical Status I–III.
Patients giving informed consent.
Patients with an anticipated difficult airway based on clinical predictors (e.g., limited mouth opening, restricted neck movement, high Mallampati grade, facial anomalies, or history of difficult intubation). 
 
ExclusionCriteria 
Details  Participants refused to sign informed consent.
ASA Physical Status IV-V.
Severe cardiovascular instability.
Pregnant or lactating women.
Patients with increased intracranial or intraocular pressure. 
 
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 
To determine the most effective sedative combination for improving intubation conditions during awake fiberoptic intubation.  To determine the most effective sedative combination for improving intubation conditions during awake fiberoptic intubation at baseline, 5min, 10min, 15min,30min 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic Stability  Hemodynamic parameters will be recorded at baseline (pre-drug), after premedication, 5 min and 10 min after infusion start, during topical anaesthesia, bronchoscope insertion, intubation, 15 min and 30 min post-intubation, every 30 min till end of surgery, at post-extubation (0 min), 15 min and 30 min post-extubation. 
Patient Comfort / Sedation (Modified OAA/S score)  Sedation score (Modified OAA/S) will be assessed at the end of loading dose infusion, before intubation, and after intubation. 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   01/12/2025 
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="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   Awake fiberoptic intubation is used in anticipated difficult airways but requires adequate sedation for patient comfort and stable hemodynamics. Midazolam is often combined with dexmedetomidine, fentanyl, or ketamine, but the best combination is unclear. This randomized double-blind trial will compare these three drug combinations in 75 adults. The primary outcome is intubation conditions. Secondary outcomes include patient comfort, sedation level, hemodynamic stability, and adverse effects. The study aims to identify the most effective and safest sedative regimen for awake fiberoptic intubation. 
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