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CTRI Number  CTRI/2012/08/002858 [Registered on: 06/08/2012] Trial Registered Prospectively
Last Modified On: 28/01/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to assess the usefulness of a new drug, Dexmedetomidine, for sedation of patients during insertion of a tube in the wind pipe using endoscopy before anaesthesia 
Scientific Title of Study   To study the effectiveness of “Dexmedetomidine” for sedation in elective awake fibre-optic intubation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1032  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JV Divatia 
Designation  Professor and Head, Department of Anaesthesia, Critical Care and Pain 
Affiliation  Tata Memorial Hopsital 
Address  Dr. E. Borges Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  jdivatia@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Konineeka Das 
Designation  Junior Resident 
Affiliation  Tata Memorial Hopsital 
Address  Dr. E. Borges Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  ckd7582@gmail.com  
 
Details of Contact Person
Public Query
 
Name  JV Divatia 
Designation   
Affiliation  Tata Memorial Hopsital 
Address  Dr. E. Borges Marg Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  jdivatia@yahoo.com  
 
Source of Monetary or Material Support  
Institutional, Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. E. Borges Marg Parel Mumbai 400012 
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 
JV Divatia  Department of Anaesthesia, Tata Memorial Hospital  Dr. E. Borges Marg Parel Mumbai 400012
Mumbai
MAHARASHTRA 
9869077435

jdivatia@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital IRB II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients requiring awake fibreoptic intubation prior to induction of general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  single intravenous loading dose of Dexmedetomidine 1.0mcg/kg over 10 mins 
Comparator Agent  Placebo  intravenous 0.9% sodium chloride for injection in volume similar to that of dexmedetomidine over 10 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Patients undergoing major head and neck surgeries scheduled for an elective nasal awake fibreoptic intubation due to an anticipated difficult airway
2)ASA Physical Status I-II. 
 
ExclusionCriteria 
Details  1)Pregnant or lactating females
2)Use of an α-2-adrenoreceptor agonist or antagonist within 14 days
3)Use of an opiod administered orally or intravenously within 1 hr or intramuscularly within 4 hrs
4)Presence of increased intracranial pressure or CSF leak
5)Acute alcohol intoxication
6)Uncontrolled seizure disorder
7)History of acute unstable angina
8)Laboratory in acute MI within past 6wks
9)Heart rate 50 beats per minute
10)Systolic blood pressure 90mmhg
11)Complete heart block unless patient had a pacemaker
12)Liver transaminase level 2 times the upper normal limit.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Ease of intubation:(acceptable score 3 to 6; not acceptable 6): median score and no. of patients
2)Percentage of patients requiring Midazolam for rescue sedation to achieve or maintain Ramsay Sedation Scale ≥2 throughout the study.
3)Patient tolerance of procedure (no. of patients with a tolerance score of 1 or 2)
4)Patient cooperation (no. of patients with a score of 1)
 
Till completion of fibreoptic intubation and induction of general anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1)Mean dose of Midazolam required and number of patients in each group requiring resuce midazolam
2)Haemodynamic instability
3)Anaesthesiologist’s assessment of ease of patient care (either easy or not easy)
4)Recall of anxiety, pain and the procedure itself during the AFOI. 
upto 24 hours after the procedure 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   06/08/2012 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways. Obtaining optimal intubating conditions when providing patient comfort and safety are the major goals while preparing the patient for fibreoptic intubation. One challenge associated with this procedure is to provide adequate sedation while maintaining a patent airway and ensuring ventilation. An ideal sedation regimen would provide patient comfort, blunting of airway reflexes, patient cooperation, haemodynamic stability, amnesia and the maintenance of a patent airway with spontaneous ventilation. Conventional sedatives like the benzodiazepines, propofol, or opiates have respiratory-depressant properties that may be detrimental in tenuous airway situations.

Dexmedetomidine is a drug whose clinical profile makes it especially well suited for sedation during awake fibreoptic intubation. It is a highly specific α2-agonist that can produce sedation, anxiolysis, analgesia, and profound levels of sedation in the absence of respiratory depression. The latter property is of special interest in difficult airway cases because during dexmedetomidine administration a stable respiratory pattern is usually seen, with little or no deterioration in respiratory pattern or change in oxygenation.

This study is specifically conducted to determine whether a loading dose of i.v. dexmedetomidine before awake fibre-optic intubation for patients with difficult airway undergoing General Anaesthesia will provide greater ease of intubation and better patient tolerability,  adequate sedation without respiratory depression and upper airway obstruction and reduced haemodynamic responses as compared to placebo. Rescue sedation will be given in both groups in case of anxiety, agitation or discomfort.

 
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