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CTRI Number  CTRI/2019/12/022499 [Registered on: 23/12/2019] Trial Registered Prospectively
Last Modified On: 19/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of dexamethasone nebulization and magnesium sulphate nebulization in patients with post operative sore throat. 
Scientific Title of Study   A comparative study of pre-operative dexamethasone nebulization and magnesium sulphate nebulization in incidence and severity of post operative sore throat. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHWETA BHARTI HEMBROM 
Designation  JUNIOR RESIDENT 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  DEPARTMENT OF ANAESTHESIOLOGY,IGIMS,PATNA PATNA BIHAR 800014 INDIA

Patna
BIHAR
800014
India 
Phone  7739132922  
Fax    
Email  ketyshweta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SHWETA BHARTI HEMBROM 
Designation  JUNIOR RESIDENT 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  DEPARTMENT OF ANAESTHESIOLOGY,IGIMS,PATNA PATNA BIHAR 800014 INDIA

Patna
BIHAR
800014
India 
Phone  7739132922  
Fax    
Email  ketyshweta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr ARVIND KUMAR 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  DEPARTMENT OF ANAESTHESIOLOGY,IGIMS,PATNA PATNA BIHAR 800014 INDIA

Patna
BIHAR
800014
India 
Phone  9534870908  
Fax    
Email  arvind007kumar@yahoo.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences, Patna 
 
Primary Sponsor  
Name  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES PATNA 
Address  SHEIKHPURA,PATNA 800014 
Type of Sponsor  Government 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 
SHWETA BHARTI HEMBROM  Indira Gandhi Institute of Medical Sciences Patna  Department of anaesthesia,first floor,ward block,IGIMS,Patna
Patna
BIHAR 		 7739132922

ketyshweta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, IGIMS, PATNA  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 
Intervention  Dexamethasone nebulization  patient will receive dexamethasone 8mg(2ml) with 3 ml of normal saline for nebulization 
Comparator Agent  Magnesium sulphate nebulization  patient will receive magnesium sulphate (50% w/v 2ml) with 3 ml of normal saline for nebulization. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  (1) Patient willing to participate
(2) Patient of ASA 1 & 2 physical status
(3) Patient between 18-55 years of age of
either sex
(4) Patient with mallampati score 1 & 2 
 
ExclusionCriteria 
Details  (1) Patient refusal to participate,
(2) Patient with ASA physical status 3 and
above
(3) Patient aged less than 18 years and
more than 55 years
(4) Patient with suspected difficult
airway and mallampati grade 3 & 4
(5) Patient with pregnancy,morbid
obesity,h/o sore throat
(6) Patient with failed intubation in two
times 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of nebulized dexamethasone with that of magnesium sulphate in decreasing the incidence and severity of post operative sore throat.  Incidence of post operative throat pain,hoarseness and cough will be assessed at 0hr,4hr,8hr,12hr and 24hr. 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects of dexamethasone and magnesium sulphate, if any  Upon discharge patient will be instructed to report when symptom appear 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 3 
Date of First Enrollment (India)   30/12/2019 
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   Plan to publish on completion of study 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Post operative sore throat is one of the common complication  of laryngoscopy and endotracheal intubation. Different agents like lignocaine jelly, ketamine gargles, iv dexamethasone, magnesium sulphate gargles & lozenges have been used with variable  success in decreasing the incidence and severity of post operative sore throat. This is  a comparativetudy to see the effects of nebulization dexamethasone and magnesium sulphate in incidence and severity of post operative sore throat. Patients will be nebulized 30 minutes before intubation in pre operative area and will be assessed post operatively for any complaints of throat pain, hoarseness and cough at 0, 4, 8, 12 & 24 hours. 
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