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CTRI Number  CTRI/2025/06/088920 [Registered on: 16/06/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Which Mouth Rinse Works Better for Soothing Sore Throat After Breast Cancer Surgery: Benzydamine or Magnesium Sulphate? 
Scientific Title of Study   Comparing the Efficacy of Benzydamine and Magnesium Sulphate Oral Gargle for Treating Postoperative Sore Throat in Patients Undergoing breast surgeries – A phase 2 randomised study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinoth kumar 
Designation  Fellow in oncoanaesthesia 
Affiliation  cancer institute, adayar 
Address  NEW NO:9&10 OLD NO.4 & 6 VADIVEL STREET west jafferkhanpet chennai
sardar patel road adayar chennai 600020
Chennai
TAMIL NADU
600083
India 
Phone  7708870341  
Fax    
Email  vin.cud@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Hariesh 
Designation  Assistant professor 
Affiliation  cancer institute, adayar 
Address  Arumbakkam,chennai
sardar patel road adayar chennai 600020
Chennai
TAMIL NADU
600106
India 
Phone  9840066898  
Fax    
Email  hariesh86@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vinoth kumar 
Designation  Fellow in oncoanaesthesia 
Affiliation  cancer institute, adayar 
Address  NEW NO:9&10 OLD NO.4 & 6 VADIVEL STREET west jafferkhanpet chennai
sardar patel road adayar chennai 600020
Chennai
TAMIL NADU
600083
India 
Phone  7708870341  
Fax    
Email  vin.cud@gmail.com  
 
Source of Monetary or Material Support  
Cancer institute, 38,sardar patel road, adayar,chennai, Tamilnadu- 600022, India 
 
Primary Sponsor  
Name  cancer institute adayar 
Address  38,sardar patel road adayar chennai, Tamilnadu - 600022, India 
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 
DrVinoth Kumar  Cancer institute, adayar  Room no- 10,PAC room, Depatment of Anaesthesiology,old surgical block
Chennai
TAMIL NADU 		 7708870341

vin.cud@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committeE, CANCER INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  benzydamine oral gargle  Patients will gargle with 15 ml of 0.15% benzydamine hydrochloride solution for 30 seconds 
Comparator Agent  magnesium sulphate oral gargle  Patients will gargle with 20mg/kg of 50% magnesium sulphate solution for 30 seconds. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Adult female patients aged more than 18 years.
POST GRADE more than or equal to 2 within 48 hours after surgery.
Patients Undergoing elective breast surgeries under general anaesthesia with endotracheal intubation complaints of sore throat.
ASA classification 1 to 3
 
 
ExclusionCriteria 
Details  Patients having Known allergy to benzydamine or magnesium sulphate
Asthmatic patients on steroid nebulisation.
Patients with History of respiratory tract infection within 1 week before surgery.
Patients with History of gastroesophageal reflux disease (GERD) or oral ulcers.
Patients unable to perform oral gargling.
Patient refusal
patients who are not extubated at the end of surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the difference in proportion of patients with reduction in POST score less than 2 assessed by four point scale between Benzydamine and magnesium sulphate oral gargle.  6 hours after the intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate difference in the duration of effect of the intervention between benzydamine and magnesium sulphate oral gargle as defined by recurrence of POST grade 2 or more after an initial response to the intervention.
• To study the difference in proportion of patients with reduction in POST score less than 2 assessed by 4 point scale between Benzydamine and magnesium sulphate oral over 24 hours after the intervention.
• To evaluate the difference in proportion of patients with stinging sensation and nausea between benzydamine and magnesium over 24 hours after the gargle administration 		 Over 24 hours after the intervention 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 2 
Date of First Enrollment (India)   01/07/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Postoperative sore throat (POST) is a common and distressing complication following endotracheal intubation during surgery with an incidence ranging from 14% to 63%. Multiple studies have been done for prevention of sore throat after tracheal intubation using topical agents such as lignocaine, steroids, benzydamine, magnesium sulphate, ketamine, dexmedetomidine and nonpharmacological measures like cuff pressure maintenance, avoidance of N2O, smaller tracheal tubes. Topical benzydamine hydrochloride and magnesium sulphate application has significantly reduced the sore throat incidence upto 24 hours with no major complications. There is paucity of literature or publications regarding the management of POST. Most of the studies discuss prevention of sore throat using topical solutions.  Currently no standard treatment guidelines exist  for managing postoperative sore throat. Most often it is neglected or managed conservatively using saline nebulisation and reassurance. When comparing saline nebulization to other topical agents, studies generally show that saline nebulization alone does not significantly reduce the incidence or severity of POST. Addressing POST will help improving the overall quality of anaesthesia care.
 There are no studies to validate the superiority or inferiority between magnesium and benzydamine oral gargle. This study is an attempt to assess the feasibility of application of these two agents in managing postoperative sore throat in patients undergoing breast surgeries under general anaesthesia. 
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