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CTRI Number  CTRI/2019/04/018616 [Registered on: 15/04/2019] Trial Registered Prospectively
Last Modified On: 01/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational Comparative study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Minimising nasal bleeding by application of decongestant drops before putting tube through nostrils 
Scientific Title of Study   Comparative efficacy of routinely used two different concentrations of intranasal topical adrenaline and xylometazoline to reduce fiberoptic-guided nasotracheal intubation associated epistaxis  
Trial Acronym  CETFONE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anil Agarwal 
Designation  Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Anaesthesia, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareilly Road

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904589  
Fax    
Email  anil_sgpgi@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shruti Somani 
Designation  MD 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Anaesthesia, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareilly Road

Lucknow
UTTAR PRADESH
226014
India 
Phone  9450344971  
Fax    
Email  shrutisomani12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shruti Somani 
Designation  MD 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Anaesthesia, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareilly Road

Lucknow
UTTAR PRADESH
226014
India 
Phone  9450344971  
Fax    
Email  shrutisomani12@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Sanjay Gandhi Postgraduate Institute of Medical Sciences  
Address  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareilly Road, Lucknow- 226014 
Type of Sponsor  Research institution and hospital 
 
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 
Shruti Somani  Sanjay Gandhi Postgraduate Institute of Health Sciences  Department of Anaesthesiology, Operation Theater Complex
Lucknow
UTTAR PRADESH 
9450344971

shrutisomani12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
102th Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Male and female patients of age 18- 65 years with American Society of Anaesthesiologists- Physical Status Grade 1 and 2 posted with indication for nasotracheal intubation i.e. undergoing surgery involving oral cavity, mandible, maxilla, thyroid, neck, difficult airway with decreased mouth opening, cervical spine, etc 
 
ExclusionCriteria 
Details  1) Patients who shall not give consent
2) Patients with nasal pathology (septal deviation, turbinate hypertrophy, nasal polyp and trauma)
3) Patients with history of common cold during prior 2 weeks or treatment with nasal decongestants, anti-histamines, NSAIDS
4) Patients with coagulopathy and on anticoagulants
5) Patients with drug allergy, chronic pain syndrome, on analgesic medication
6) Pregnant patients
 
 
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 
Comparison of incidence and severity of epistaxis during fiberoptic-guided nasotracheal intubation  At the time of intubation  
 
Secondary Outcome  
Outcome  TimePoints 
1) Hemodynamic changes following administration of topical vasoconstrictor agents
2) Patient discomfort, pain and satisfaction scoring 24 hours after extubation
 
1)Hemodynamic changes at time 0 minute, 1 minute, 10 minutes following administration of topical vasoconstrictor agents
2) Patient discomfort, pain and satisfaction scoring 24 hours after extubation 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "172"
Final Enrollment numbers achieved (India)="172" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/04/2019 
Date of Study Completion (India) 31/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/10/2019 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No Publication Details uptil now 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Nasotracheal intubation is a specialized procedure performed before surgeries involving oral cavity, pharynx, larynx, maxilla, mandible, neck, cervical spine within its surgical field. Nasotracheal intubation provides better access to these areas and a wider surgical field. Most commonly encountered problem faced during this procedure is epistaxis. To avoid it, nasal cavity has to be prepared adequately. One of the most commonly used method for preparation is topical application of vasoconstrictive agents and lubrication. Many studies have been performed regarding the choice of vasoconstrictors and comparing one with the other. We did not find any literature comparing xylometazoline and adrenaline or comparing two different concentrations of adrenaline, though both these agents have been found to maximally reduce epistaxis. So, we wish to compare between these three topical preparations and conclude the best amongst the three. Following approval by the Institutional Ethics Committee, study would be completed in the period of 18 months. After taking written and informed consent from the patient’s relative, this study would be conducted in adult patients (18-65yrs), of either sex, undergoing elective surgery requiring general anaesthesia with nasotracheal intubation. The incidence and severity of epistaxis would be noted while using three different vasoconstrictors during fiberoptic guided nasotracheal intubation. Also 24 hours post-intubation nasal discomfort and pain would be graded by VAS Score.

 
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