FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/03/031760 [Registered on: 08/03/2021] Trial Registered Prospectively
Last Modified On: 10/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison Of a sedative drug with a combination with opioid for awake intubation in Patients with difficult airway. 
Scientific Title of Study   Comparison of dexmedetomidine alone with dexmedetomidine and fentanyl during awake fibre-optic intubation in patients with difficulty in intubation: A Randomised Clinical Trail 
Trial Acronym  Dexfen 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyangshu Koushik 
Designation  Pg student 
Affiliation  IMS and SUM hospital  
Address  First floor, opposite modular 3 complex, Department of anaesthesiology and critical care, sum hospital Bhubaneswar Odisha 751019
First floor, opposite modular 3 complex, Department of anaesthesiology and critical care, sum hospital K8 kalinganagar ghatikia Bhubaneswar Odisha 751003
Khordha
ORISSA
751019
India 
Phone  9972490992  
Fax    
Email  priyangshukoushik25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhavna sriramka 
Designation  Assistant professor 
Affiliation  IMS and SUM hospital  
Address  First floor, opposite modular 3 complex, Department of anaesthesiology and critical care, sum hospital Bhubaneswar Odisha 751019
First floor, opposite modular 3 complex, Department of anaesthesiology and critical care, sum hospital K8 kalinganagar ghatikia Bhubaneswar Odisha 751003
Khordha
ORISSA
751019
India 
Phone  7751007807  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyangshu Koushik 
Designation  Pg student 
Affiliation  IMS and SUM hospital  
Address  First floor, opposite modular 3 complex, Department of anaesthesiology and critical care, sum hospital Bhubaneswar Odisha 751019
First floor, opposite modular 3 complex, Department of anaesthesiology and critical care, sum hospital K8 kalinganagar ghatikia Bhubaneswar Odisha 751003
Khordha
ORISSA
751019
India 
Phone  9972490992  
Fax    
Email  priyangshukoushik25@gmail.com  
 
Source of Monetary or Material Support  
IMS ans SUM Hospital Bhubaneswar  
 
Primary Sponsor  
Name  IMS and SUM Hospital  
Address  K8 Kalinga nagar Ghatikia 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 
Priyanghsu Koushik  IMS and SUM Hospital   Department of Anesthesia Critical Care and Pain medicine K8 Kalinga nagar Ghatikia Bhubaneswar Odisha 751003
Khordha
ORISSA 		 9972490992

priyangshukoushik25@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute of Medical Sciences and SUM Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  An infusion of 1 mcg/kg dexmedetomidine diluted in normal saline to make it a total volume of 50 ml to be started for 10 mins prior to starting the procedure for awake intubation. 
Comparator Agent  Dexmedetomidine and fentanyl  An infusion of 0.5 mcg/kg dexmedetomidine with 1 mcg/kg fentanyl diluted in normal saline to make it a total volume of 50 ml to be started for 10 mins prior to starting the procedure for awake intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. ASA grade I and II
2. Patients with difficult intubation 
 
ExclusionCriteria 
Details  1. Refusal of patient to participate in the study
2. ASA grade II/ III
3. Any allergy to dexmedetomidine
4. Patients on any of the following:
a. Higher degree of A-V block
b. Treatment with ACE Inhibitors, digoxin or beta adrenergic antagonist
c. Treatment with alpha-2 agonist
d. Long term use of benzodiazepine or TCA
e. Treat with anticoagulants
5. Bleeding disorders
6. Pregnant and nursing women
7. Morbid obesity
8. Lack of cooperative and effective communication
9. Patients requiring post operative ventilatory support  
 
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. Airway obstruction score was evaluated using a 3 degree scale
2. Intubation score was evaluated according to Vocal cord movement
3. Coughing
4. Limb movement
5. Fiberoptic intubation comfort score indicating patient tolerance; It was evaluated using a 5 point score
6. Ramsay sedation score: using 6 points
7. Patient satisfaction score
 		 At the time of attempting awake fibre optic intubation  
 
Secondary Outcome  
Outcome  TimePoints 
1. Haemodynamic variables:
a. heart rate
b. systolic blood pressure
c. diastolic blood pressure
2. Any episode of oxygen desaturation ( less than 90%) or bradycardia (HR less than 60 beats/minute). 		 Haemodynamic variables:
1. Baseline: Before drug administration.
2. With the start of the airway manipulation technique (20 min after drug administration).
3. Immediately after intubation.
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/03/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Awake fiber-optic intubation is a gold standard of management of predicted difficult airway. Sedation is frequently used to make the process more tolerable to the patient. It is not always easy to strike a balance between patient comfort and a good intubating condition on one hand and maintaining ventilation and a patent airway on the other. This study is designed to assess the level of sedation and hemodynamic changes with different doses of pre-operative dexmedatomidine infusion at 1mcg/kg alone Vs. 0.5mcg/kg dexmedetomidine with 1 mcg/kg fentanyl infusion among the study groups. 
Close