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
|
|
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
|
|
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
|
|
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
|
|
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. |