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CTRI Number  CTRI/2024/09/073684 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 06/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two intravenous drugs(Dexmedetomidine with Ketamine and Dexmedetomidine with Fentanyl) for passing tube (Endotracheal tube) via nose with help of Instrument (fiber scope) in patients without anaesthesia (in awake patients) 
Scientific Title of Study   Comparison between IV Dexmedetomidine with Ketamine and IV Dexmedetomidine with Fentanyl on Intubating Conditions During Awake Fibreoptic Intubation: A Prospective Randomised Double Blind study 
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 Sandeep Sharma 
Designation  Professor 
Affiliation  R.N.T Medical College 
Address  Department of Anaesthesia, R.N.T Medical College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  09214323557  
Fax    
Email  sharma0979@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Sharma 
Designation  Professor 
Affiliation  R.N.T Medical College 
Address  Department of Anaesthesia, R.N.T Medical College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  09214323557  
Fax    
Email  sharma0979@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shrikrishan Choudhary 
Designation  Post Graduate Resident 
Affiliation  R.N.T Medical College 
Address  Department of Anaesthesia, R.N.T Medical College Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9610002209  
Fax    
Email  shrikrishan6205@gmail.com  
 
Source of Monetary or Material Support  
R.N.T Medical College Department of Anaesthesiology udaipur Rajasthan india 313000 
 
Primary Sponsor  
Name  Maharana Bhupal Government Hospital 
Address  Department of Anaesthesia R.N.T Medical College Udaipur Rajasthan india 313000 
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 Shrikrishan Choudhary  MB Government Hospital  ENT OT 2nd floor Main Building and Neurosurgery OT 5th Floor SSB Building MB Government Hospital
Udaipur
RAJASTHAN 		 9610002209

shrikrishan6205@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS UDAIPUR  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, (2) ICD-10 Condition: H711||Cholesteatoma of tympanum, (3) ICD-10 Condition: H701||Chronic mastoiditis, (4) ICD-10 Condition: H720||Central perforation of tympanic membrane, (5) ICD-10 Condition: G542||Cervical root disorders, not elsewhere classified, (6) ICD-10 Condition: G543||Thoracic root disorders, not elsewhere classified, (7) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified, (8) ICD-10 Condition: M266||Temporomandibular joint disorders, (9) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (10) ICD-10 Condition: M265||Dentofacial functional abnormalities, (11) ICD-10 Condition: S120||Fracture of first cervical vertebra, (12) ICD-10 Condition: S121||Fracture of second cervical vertebra, (13) ICD-10 Condition: S320||Fracture of lumbar vertebra, (14) ICD-10 Condition: S342||Injury of nerve root of lumbar andsacral spine, (15) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (16) ICD-10 Condition: S026||Fracture of mandible, (17) ICD-10 Condition: G892||Chronic pain, not elsewhere classified, (18) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AWAKE FIBEROPTIC INTUBATION  Comparison between IV Dexmedetomidine (1mcg/kg) with Ketamine(40mg) and IV Dexmedetomidine(1mcg/kg) with Fentanyl(2mcg/kg) on intubating condition during awake fiberoptic intubation (Up To 10 min after intubation) 
Comparator Agent  IV Dexmedetomidine and IV Fentanyl in Awake Fibreoptic Intubation  IV Dexmedetomidine( 1mcg/kg) diluted up to 50ml in normal saline over 15minute followed by infusion of IV Fentanyl (2mcg/kg) diluted up to 10ml in normal saline over 5minutes 
Comparator Agent  IV Dexmedetomidine and IV Ketamine in Awake Fibreoptic Intubation  Intravenous Dexmedetomidine (1mcg/kg) diluted up to 50ml in normal saline over 15minutes followed by infusion of IV Ketamine (40mg) diluted up to 10ml in normal saline over 5minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with ASA Grade I and II
Patient undergoing elective surgery under general anaesthesia
Patient with Mallampati Class I and II 
 
ExclusionCriteria 
Details  Patient refusal
Psychiatric patients
Emergency surgery
Patients with severe bradycardia/heart block
Pregnant and lactating mother
Patients having known allergy to any drug used in the study
Patients contraindicated to nasal intubation such as grossly distorted airway anatomy, URTI and bleeding disorders
Patients on long term opioids or sedative medications 
 
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 
Cough score(severity of cough) during awake fibreoptic intubation  Up to 2 Min after awake fibreoptic intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Intubating conditions
Vocal cord position
Post intubation score
Ramsay sedation score
Hemodynamic parameters
Side effects/complications if any 		 Up to 24-hours postoperatively 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) 31/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   We would like to compare intravenous dexmedetomidine with intravenous Ketamine and intravenous dexmedetomidine with intravenous Fentanyl on intubating conditions during awake fiberoptic intubation in term of cough score, intubating condition, Ramsay sedation score , hemodynamic parameters, side effects/complications if any. Kindly grant CTRI registration for our study as IV Dexmedetomidine with ketamine and IV Dexmedetomidine with Fentanyl are FDA approved drugs.   
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