FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/11/037832 [Registered on: 08/11/2021] Trial Registered Prospectively
Last Modified On: 05/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare three different doses of dexmedetomidine in patients undergoing awake fibreoptic intubation  
Scientific Title of Study   PROSPECTIVE RANDOMIZED COMPARATIVE STUDY BETWEEN THREE DIFFERENT DOSES OF DEXMEDETOMIDINE ON INTUBATION CONDITIONS IN AWAKE NASOTRACHEAL FIBREOPTIC BRONCHOSCOPY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanya Arora 
Designation  Junior Resident 
Affiliation  DY Patil Hospital  
Address  DY PATIL MEDICAL COLLEGE Sector 5 Nerul

Thane
MAHARASHTRA
400706
India 
Phone  9027011111  
Fax    
Email  sanya.a24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Balasaheb Govardhane 
Designation  Associate Professor 
Affiliation  DY Patil Hospital  
Address  DY PATIL MEDICAL COLLEGE Sector 5 Nerul

Thane
MAHARASHTRA
400706
India 
Phone  9027011111  
Fax    
Email  drbgovardhane@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sanya Arora 
Designation  Junior Resident 
Affiliation  DY Patil Hospital  
Address  DY PATIL MEDICAL COLLEGE Sector 5 Nerul


MAHARASHTRA
400706
India 
Phone  9027011111  
Fax    
Email  sanya.a24@gmail.com  
 
Source of Monetary or Material Support  
DY PATIL MEDICAL COLLEGE 
 
Primary Sponsor  
Name  DY Patil Medical College 
Address  DY PATIL MEDICAL COLLEGE Vijay Hostel 
Type of Sponsor  Private hospital/clinic 
 
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 
SANYA ARORA  DEPARTMENT OF ANESTHESIA ,DY PATIL MEDICAL COLLEGE  DY PATIL MEDICAL COLLEGE Sector 5 Nerul
Thane
MAHARASHTRA 		 9027011111

sanya.a24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for biomedical and healthcare research   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 
Comparator Agent  Dexmedetomidine  There will be a comparison of three doses of dexmeditomidine i.Group D1. will recieve an infusion of 1.5mcg/kg dexmedetomidine diluted in 50 ml saline ii. Group D2: will receive an infusion of 1mcg/kg dexmedetomidine diluted in 50 ml saline iii. Group D3: will receive an infusion of 0.5mcg/kg dexmedetomidine diluted in 50 ml saline  
Intervention  Fibreoptic Nasotracheal Intubation   Intubation of Difficult airway patients with inadequate mouth opening with fibreoptic bronchoscopy  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 All patient giving consent
2 Patient undergoing elective oro-maxillo-facial and oral malignancy surgeries
3 Patients >18 years or <60 years
4 Patients of either sex
5 ASA grade I and II
 
 
ExclusionCriteria 
Details  1 Patients not consenting
2 Patient with coagulopathies or on anticoagulants
3 Nasal mass or Adenoids
4 Patients with severe renal, hepatic, respiratory or cardiac diseases, infection at the site of the block, pregnancy and neuromuscular disorders
5 Patients with any known allergy to dexmedetomidine
6 Patients with any contraindication to dexmedetomidine
7 Lack of cooperation or effective communication

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare between three different doses of dexmedetomidine for sedation on intubation condition in awake nasotracheal fiberoptic intubation.
The primary objective is to compare between three groups: Intubation score, patients’ tolerance, 3-point assessment score immediately after nasotracheal intubation, hemodynamic parameters and incidence of oxygen desaturation if any.
 		 To compare pre infusion, 5 mins after infusion, 10 mins after infusion, pre intubation, during intubation and post intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective is to observe side effects of drug, if any   1.5 years 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   30/11/2021 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 nasal fiberoptic intubation (ANFOI) is an established method of securing difficult airway recommended for patients with anticipated difficult airway, failed intubation, unstable cervical spine injury where optimum positioning for laryngoscopy is difficult to achieve. Both optimal intubating conditions and patients’ comfort are paramount while preparing the patient for fiberoptic intubation. It is essential to prepare the patients prior to ANFOI. The preparation includes obtundation of airway reflexes, adequate sedation, anxiolysis along with preservation of patent airway and adequate ventilation.

In the present study we will compare three different doses of dexmedetomidine for conscious sedation during ANFOI in adult patients scheduled for elective oro-maxillo-facial and oral malignancy surgeries. In very few studies dexmedetomidine is used as a single agent for induction for sedation during awake ANFOI. We evaluate 3 different doses of dexmedetomidine to establish conscious safe regimen of sedation

Hence, this study was undertaken to compare the different doses of dexmedetomidine for evaluating intubating conditions during ANFOI

The aim of our study is to compare the effectiveness of different doses of dexmedetomidine for evaluating intubation condition, patient’s tolerance, hemodynamic parameters and incidence of oxygen desaturation, if any.

 


 
Close