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CTRI Number  CTRI/2020/02/023609 [Registered on: 26/02/2020] Trial Registered Prospectively
Last Modified On: 25/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effectiveness of dexamethasone nebulisation on preventing postoperative sore throat occuring in prone position surgeries  
Scientific Title of Study   The effect of dexamethasone nebulisation on postoperative sore throat in prone position surgery: A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay R Nayak 
Designation  Post Graduate 
Affiliation  M.S Ramaiah Medical College 
Address  Department of Anaesthesiology, M.S. Ramaiah Medical College, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  8861106193  
Fax    
Email  sanjayrnayak1993@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sadasivan S Iyer 
Designation  Assistant Professor 
Affiliation  M.S Ramaiah Medical College 
Address  Department of Anaesthesiology, M.S. Ramaiah Medical College, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  8971026127  
Fax    
Email  sadashivaniyer@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay R Nayak 
Designation  Post Graduate 
Affiliation  M. S Ramaiah Medical College 
Address  Department of Anaesthesiology, M.S. Ramaiah Medical College, Bangalore

Bangalore
KARNATAKA
560054
India 
Phone  8861106193  
Fax    
Email  sanjayrnayak1993@gmail.com  
 
Source of Monetary or Material Support  
M. S Ramaiah Medical College and Hospitals. Department of Anaesthesiology, M.S. Ramaiah Medical College, Bangalore Bangalore KARNATAKA 560054  
 
Primary Sponsor  
Name  MS Ramaiah Medical College and Hospitals 
Address  Department of Anaesthesiology, M.S. Ramaiah Medical College, Bangalore 
Type of Sponsor  Private 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 Sanjay R Nayak  M.S. Ramaiah Medical College and Hospitals  Department of Anaesthesiology, M.S.Ramaiah Medical College, Bangalore
Bangalore
KARNATAKA 		 8861106193

sanjayrnayak1993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee M.S Ramaiah Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone  Dexamethasone nebulisation given at dose of 0.1mg/kg diluted with saline to 5ml (single dose)  
Intervention  Dexamethasone   Dexamethasone nebulisation given at dose of 0.2mg/kg diluted with saline to 5ml (single dose) 
Comparator Agent  Normal saline   Normal saline 5ml given as a nebulisation (single dose) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA I to III patients.
2.Patients undergoing elective surgeries in prone position 
 
ExclusionCriteria 
Details  1. History of recent respiratory tract infections
2. History of NSAID or steroid usage
3. Previously undergone head and neck surgeries
4. Patients with preoperative sore throat
5. Pregnant women
6. Duration of tracheal intubation less than 60 minutes or more than 300 minutes
7. Patients who require a nasogastric tube
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the incidence and severity of post-operative sore throat with and without dexamethasone nebulisation in patients undergoing surgeries in prone position.  At 0, 2, 6, 12 and 24 hours after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the incidence and severity of post-operative hoarseness of voice and cough with and without dexamethasone nebulisation in patients undergoing surgeries in prone position.  At 0, 2, 6, 12 and 24 hours after extubation.  
 
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)   01/03/2020 
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="2"
Months="0"
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)?  

Brief Summary  

Positional Change From Supine To Prone During Surgery Is Associated With Changes In Endotracheal Tube Cuff Pressures And Displacement Of The Endotracheal Tube, Hence Resulting In A Greater Incidence Of Post Operative Sore Throat And Hoarseness Of Voice. Many Studies Have Focused On The Effect Of Intravenous As Well As Nebulised Dexamethasone On Post Operative Sore Throat In Supine Position Surgeries, This Study Aims To Study The Effect Of Dexamethasone Nebulisations On Post Operative Sore Throat In Patients Undergoing Surgery In Prone Position.

 
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