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CTRI Number  CTRI/2020/02/023647 [Registered on: 28/02/2020] Trial Registered Prospectively
Last Modified On: 27/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study to see the effects of drug on incidence and severity of post operative sore throat 
Scientific Title of Study   Comparative study to see the effects of different dosage of intracuff dexamethasone on incidence and severity of post operative sore throat 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavna Gupta 
Designation  Assistant Professor 
Affiliation  AIIMS hospital, Rishikesh 
Address  Level 6, AIIMS hospital, Rishikesh Uttrakhand Tehri Garhwal UTTARANCHAL 249203 India

Garhwal
UTTARANCHAL
249203
India 
Phone  8527686660  
Fax    
Email  bhavna.kakkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhavna Gupta 
Designation  Assistant Professor 
Affiliation  AIIMS hospital, Rishikesh 
Address  Level 6, AIIMS hospital, Rishikesh Uttrakhand Tehri Garhwal UTTARANCHAL 249203 India

Garhwal
UTTARANCHAL
249203
India 
Phone  8527686660  
Fax    
Email  bhavna.kakkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhavna Gupta 
Designation  Assistant Professor 
Affiliation  AIIMS hospital, Rishikesh 
Address  Level 6, AIIMS hospital, Rishikesh Uttrakhand Tehri Garhwal UTTARANCHAL 249203 India

Garhwal
UTTARANCHAL
249203
India 
Phone  8527686660  
Fax    
Email  bhavna.kakkar@gmail.com  
 
Source of Monetary or Material Support  
AIIMS hospital 
 
Primary Sponsor  
Name  Department of anaesthesiology AIIMS Rishikesh 
Address  AIIMS Rishikesh Veer Bhadra Marg uttrakhand  
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 
Bhavna Gupta  AIIMS  Department of Anesthesia, 6th Floor, AIIMS hospital Vir-bhadra Marg Rishikesh uttrakhand Garhwal UTTARANCHAL
Garhwal
UTTARANCHAL 		 8527686660

bhavna.kakkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  fit and healthy individuals  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Assessment and comparison of different doses of intra-cuff dexamethasone on post-extubation sore throat  Randomization will be done by computer generated random number tables and groups will be assigned by opening sealed sequentially numbered opaque envelopes immediately before surgery. Patients will be blinded to their group allocation. All the study drugs will be constituted into a total volume of 5ml with normal saline to permit blinding. The drugs will be loaded and prepared by an independent anesthesiologist in identical syringes and investigator who will be administering the drugs in the cuff will be blinded to the contents. The adequate cuff inflation will be achieved by using additional normal saline to achieve desired and optimum ventilation. The assessment of POST and other complications will be done by the investigator who is blinded to the contents. Assessment of POST: The assessment of sore throat and hoarseness will be done at one hour, 6 hr and 24 hrs post extubation. Scoring system will be as follows: POST 0 - no sore throat 1 - Minimal sore throat 2 - Moderate sore throat 3 - Severe sore throat  
Intervention  assessment of reduction in post- extubation sore throat after administration of study drugs in the cuff of endotracheal tube (ETT) in patients requiring intubation  Dexamethasone in two different doses of 0.1mg/kg, 0.2 mg/kg respectively and normal saline will be used as study drugs for inflation of ETT cuff. We will also assess any other complications like hoarseness, dysphonia and airway dysphoria. Other beneficial effects in addition to reducing airway complications will too be evaluated.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. The population between age group of 18 year to 65 years, weighing 40-80 kg.
2. Patients belonging to ASA I or II.
3. Patients receiving general anaesthesia with endotracheal intubation for elective surgery
 
 
ExclusionCriteria 
Details  The study will exclude:
1. Patients with history of recent respiratory tract infection or sore throat.
2. History of neuromuscular disease.
3. Duration of tracheal intubation of < 60 min or > 240 min and requiring more than one attempt for tracheal intubation.
4. Preoperative use of analgesics or steroids.
5. History of laryngeal or tracheal surgery or pathology
6. Any patients with diabetes mellitus and obesity will also be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of POST:
The assessment of sore throat and hoarseness will be done at one hour, 6 hr and 24 hrs post extubation. Scoring system will be as follows:
POST
0 - no sore throat
1 - Minimal sore throat
2 - Moderate sore throat
3 - Severe sore throat
 		 1 h, 6 h, 24 h 
 
Secondary Outcome  
Outcome  TimePoints 
HOARSENESS
0- No complaint of hoarseness
1- Minimal change in quality of speech (minimal hoarseness)
2- Moderate change in quality of speech (moderate hoarseness)
3- Gross change in the quality of speech (severe hoarseness)
 		 1h, 6h, 24 h 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   29/02/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is aimed at assessment of reduction in post- extubation sore throat after administration of study drugs in the cuff of endotracheal tube (ETT) in patients requiring intubation for various surgeries. Dexamethasone in two different doses of 0.1mg/kg, 0.2 mg/kg respectively and normal saline will be used as study drugs for inflation of ETT cuff. We will also assess any other complications like hoarseness, dysphonia and airway dysphoria. Other beneficial effects in addition to reducing airway complications will too be evaluated. The results can help us in finding the effectivity of dexamethasone for alleviating POST and the optimal dose for same. It can further pave way for anaesthetists to conduct studies in patients predisposed to increased airway morbidity like obese, paediatric, head and neck surgeries, surgeries in prone position etc. 

Assessment of POST:

The assessment of sore throat and hoarseness will be done at one hour, 6 hr and 24 hrs post extubation. Scoring system will be as follows:

POST

0        -  no sore throat

1        -  Minimal sore throat

2        -  Moderate sore throat

3        -  Severe sore throat

HOARSENESS

0-      No complaint of hoarseness

1-       Minimal change in quality of speech (minimal hoarseness)

2-      Moderate change in quality of speech (moderate hoarseness)

3-       Gross change in the quality of speech (severe hoarseness)
Analysis: Continuous variables will be presented as a mean ± standard deviation. If the values are unevenly distributed, categorical variables will be expressed as frequencies (%). Categorical variables will be compared between the groups using the Chi‑square test with the Fisher’s exact test where applicable. Continuous variables will be compared between the groups using analysis of variance. Post‑hoc analysis would be performed using the Bonferroni test. Value of p < 0.05 would be considered statistically significant. The analysis will be done using Statistical Package for the Social Sciences software, Version 21.0 (IBM Corp., Armonk, NY, USA). 
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