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CTRI Number  CTRI/2022/08/044924 [Registered on: 25/08/2022] Trial Registered Prospectively
Last Modified On: 31/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Sore throat after surgery 
Scientific Title of Study   Comparison of topical Betamethasone gel and Nebulised Dexamethasone in attenuating Post Operative Sore Throat in patients undergoing Surgeries under General Anaesthesia- a randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr CH Rama Krishna Prasad 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Room no- 49, A block, ground floor, All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
Hyderabad
Hyderabad
TELANGANA
500004
India 
Phone  09885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr CH Rama Krishna Prasad 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Room no- 49, A block, ground floor, All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
Hyderabad
Hyderabad
TELANGANA
500004
India 
Phone  09885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr CH Rama Krishna Prasad 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Room no- 49, A block, ground floor, All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
Hyderabad
Hyderabad
TELANGANA
500004
India 
Phone  09885718133  
Fax    
Email  ramakrishna.chikkala19@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Room no- 49, A block, ground floor, All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Department of Anaesthesiology, Room no- 49, A block, ground floor, All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126  
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 
CH RAMA KRISHNA PRASAD  All India Institute of Medical Sciences  Department of Anaesthesiology, Room no- 49, A block, ground floor, All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
Hyderabad
TELANGANA 
09885718133

ramakrishna.chikkala19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS ETHICS COMMITTEE  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  Betamethasone   Betamethasone 0.05% TOPICAL ( over the endotracheal tube) sore throat and cough after topical betamethasone applied on ET tube 
Comparator Agent  Dexamethsone   Dexamethsone 8 mg 5 minutes before surgery via Nebulisation once sore thorat and cough after giving nebulised dexamethasone  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with ages between 18-60 years
ASA Physical Status of 1 & 2
Patients undergoing elective procedures under general anaesthesia with expected surgical duration below 6 hours
 
 
ExclusionCriteria 
Details  Pre existing sore throat/ hoarseness on pre op assessment
Recent lower respiratory tract infection
Known hypersensitivity to steroids
Procedure more than 6 hours
Oral and neck surgeries
Pregnant patients
Patients with cognitive disabilities
Patients requiring NG tube insertion
Patients requiring Rapid Sequence Induction, Intubation
Patients requiring use of Succinyl Choline for neuromuscular blockade
Difficult intubation
Use of additional gadgets such as bougie, stylets for aiding in intubation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Sore throat  at 4 hours,8 hours , 12 hours,24 hours and 48 hours after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
cough  at 4 hours, 8 hours,12 hours,24 hours,48 hours after extubation 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/08/2022 
Date of Study Completion (India) 31/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Though Post Operative Sore throat is a minor complication after General Anaesthesia, but it poses immense discomfort to the patient.It leads to cough which may cause strain at the suture site eventually effects the healing. In this era of day care surgery and enhanced recovery of the patients after the surgery, patient should be able to return to his/her routine activity without any discomfort/limitation as early as possible. Though considered as a minor complication by many clinicians,sore throat/hoarseness/cough in the post operative period poses high risk of patient discomfort and dissatisfaction after the surgery. Total incidence of post operative sore throat is around 68%.Various pharmacological and non pharmacological methods were tried with variable success rate.The underlying cause for POST might be trauma to the oropharynx, base of tongue, or posterior pharyngeal wall or inflammationsecondary to trauma caused by airway device used. Trauma to epithelial layer or deeper layers of vocal cords may initiate inflammation leading to edema. Anti inflammatory drugs will be effective in countering the inflammation caused by the trauma to the airway/ mucosa. Steroids are one such group of drugs which help in reducing the inflammation caused by the initial insult/trauma. Hence usage of steroids in various formulations and various routes were tried to attenuate the initial inflammation caused due to endo tracheal intubation in the airway mucosa eventually hypothecating that there would be reduction in incidence of post operative sore throat.Steroids reduce the production of inflammatory mediators, prostaglandins, and leukotrienes. The mechanism behind this is inhibition of phospholipase-A2 through production of calcium-dependent phospholipid-binding proteins known as annex-ins and cyclo-oxygenase. Hence, the efficacy of two highly potent steroids betamethasone and dexamethasone given topical and nebulised forms respectively prior to intubationis compared in reduction of incidence of POST.There is a limited literature available in testing the efficacy of highly potent topical betamethasone preparation when applied to the Endotracheal tube. So, we attempted to study the efficacy of topical Betamethasone gel when compared with nebulised dexamethasone in reducing the incidence of post operative sore throat.

 
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