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CTRI Number  CTRI/2025/05/087160 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 17/05/2025
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 Dexmedetomidine and Remifentanil medications used to keep patients calm and comfortable while they are awake during a placement of breathing tube in difficult patients 
Scientific Title of Study   Comparasion of dexmedetomidine and remifentanil for sedation during awake fibre-optic intubation in patients with difficult airway- a randomized clinical control trial 
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 Prasanth Sai Vangapulusu 
Designation  Post Graduate student 
Affiliation  IMS AND SUM HOSPITAL 
Address  Dept of Anesthesia, IMS AND SUM HOSPITAL, Siksha O Anusandhan University, Kalinganagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  7032393230  
Fax    
Email  prasanthsai000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjita Acharya 
Designation  Professor 
Affiliation  IMS AND SUM HOSPITAL 
Address  Dept of Anesthesia, IMS AND SUM HOSPITAL, Siksha O Anusandhan University, Kalinganagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8763421899  
Fax    
Email  drranjitaacharya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasanth Sai Vangapulusu 
Designation  Post Graduate student 
Affiliation  IMS AND SUM HOSPITAL 
Address  Dept of Anesthesia, IMS AND SUM HOSPITAL, Siksha O Anusandhan University, Kalinganagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  7032393230  
Fax    
Email  prasanthsai000@gmail.com  
 
Source of Monetary or Material Support  
IMS AND SUM HOSPITAL, Siksha O Anusandhan University, Bhubaneswar, Odisha, India, 751003 
 
Primary Sponsor  
Name  IMS and SUM Hospital 
Address  K8, Kalinganagar, Bhubaneswar, Odisha, 751003 
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 Prasanth Sai Vangapulusu  IMS AND SUM HOSPITAL  Onco surgery OT, Dental OT, IMS AND SUM HOSPITAL, K8, Kalinganagar, Bhubaneswar, Odisha, 751003
Khordha
ORISSA 
7032393230

prasanthsai000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IMS AND SUM HOSPITAL  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  Dexmedetomidine  Dexmedetomidine loading dose of 0.5µg/kg over 10 minutes Intravenously and continuous infusion at 0.3 µg/kg/hr Intravenously given till appropriate sedation level reached 
Comparator Agent  Remifentanil  Remifentanil loading dose of 0.75µg/kg for 5 minutes Intravenously and continuous infusion at 0.15 µg/kg/min Intravenously given till appropriate sedation reached 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists grades 1 and 2,Undergoing oral cancer or dental surgeries,Patients with limited mouth opening of less than 2 fingers
 
 
ExclusionCriteria 
Details  Patient not giving consent,known allergy to the anesthetics,Coagulation disorders,Pregnancy or breast feeding,Cardiovascular and neurological abnormalities,Non cooperative patients
Patients belonging to ASA more than 2,Patients with alcohol or drug use
 
 
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 assess the ease of intubation between both the groups  1 minute, 5 minute, 10 minute, 15 minute intervals 
 
Secondary Outcome  
Outcome  TimePoints 
To assess intubation comfort score,To study complications, cardio respiratory status intra operatively,Ramsay Sedation scale,Airway obstruction score,Time for Intubation  1 minute, 5 minute, 10 minute, 15 minute intervals 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   30/05/2025 
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 AFOI is a well established technique for managing patients with difficult airways However the biggest challenge with AFOI is ensuring that patients are comfortable cooperative and not overly anxious while still maintaining their airway reflexes and spontaneous breathing

Dexmedetomidine a sedative that works on alpha2 adrenergic receptors is known for providing calmness pain relief and anxiety reduction without significantly affecting breathing On the other hand remifentanil a short acting opioid is commonly used for its strong pain relief and ability to suppress airway reflexes though it comes with a risk of respiratory depression if not carefully controlled

While both drugs are used in clinical practice for AFOI there is still no clear consensus on which one is better particularly in patients with difficult airways Since these patients are already at a higher risk of complications choosing the right sedation strategy could make a significant difference in their safety and comfort

Although previous studies have explored dexmedetomidine and remifentanil for AFOI most research has focused on patients with normal or mildly challenging airways There is limited evidence comparing these two sedatives specifically in cases where airway management is particularly difficult due to anatomical abnormalities trauma or other complications Additionally while both drugs are effective still dont have a clear understanding of which one provides a better balance between patient comfort intubation success and minimal side effects especially in high risk cases

Dexmedetomidine will offer a more stable sedation experience with fewer airway reflex disturbances better patient tolerance and more consistent hemodynamic stability compared to remifentanil

 
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