FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056990 [Registered on: 28/08/2023] Trial Registered Prospectively
Last Modified On: 24/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the efficacy of magnesium sulphate and ketamine gargles on incidence and severity of post-operative sore throat following endotracheal intubation. 
Scientific Title of Study   To compare the efficacy of magnesium sulphate gargles and ketamine gargles on incidence and severity of post-operative sore throat following endotracheal intubation. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Kumar P B 
Designation  Professor and HOD 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd Floor, No.67, BGS Health and Education City, Uttarahalli Main Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9448279414  
Fax    
Email  drrameshkumarpb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arunagiri 
Designation  Junior Resident 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd Floor, No.67, BGS Health and Education City, Uttarahalli Main Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9442225100  
Fax    
Email  arunarunagiri12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shruti Rao 
Designation  Assistant Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd Floor, No.67, BGS Health and Education City, Uttarahalli Main Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9820959597  
Fax    
Email  drshrutirrao@gmail.com  
 
Source of Monetary or Material Support  
BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India 
 
Primary Sponsor  
Name  Dr. Ramesh Kumar P B 
Address  BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India 
Type of Sponsor  Other [Self] 
 
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 Ramesh Kumar PB  BGS Global Institute of Medical Sciences  Major OT Complex, 3rd Floor, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 9448279414

drrameshkumarpb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  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 
Comparator Agent  Ketamine gargle   Ketamine - 30 mg in 20% dextrose water total volume 30 ml 
Intervention  Magnesium sulphate   Magnesium sulphate 1.2 g in 20% dextrose water total volume 30 ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients requiring general anaesthesia with Proseal laryngeal mask airway.
2. Physical status ASA grade I and II.
 
 
ExclusionCriteria 
Details  1.Patients with history of pre-operative sore throat, asthma, COPD.
2.Patients requiring oropharyngeal, head and neck surgeries.
3.Patients with Body Mass Index > 30 kg/m2.
4.Patients with full stomach or abdominal distension.
5.Patients with gastroesophageal reflux disease.
6.Patients with modified mallampatti class IV, anticipated difficult airway.
7.Patients having allergy to study drugs.
8.Patients who have recently received NSAIDS.
9.Patients having nausea and vomiting.
10.Expected duration of surgery more than 2 hours.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post-operative sore throat  Assessed at 0, 2, 4, 24 hrs post-operatively & graded on a four-point scale 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of Analgesics for POST & Side Effects profile of study drugs.  VAS scoring POST to be assessed at 0,2,6,24 hours post operatively  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   04/09/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Post-operative sore throat (POST) is a common adverse event after general anaesthesia. Though considered as a minor complication, it may cause significant post-operative morbidity and patient dissatisfaction. Ketamine, an NMDA receptor antagonist, has been used as gargle, for reducing the incidence and severity of POST following endotracheal intubation. Magnesium sulphate, also an NMDA receptor antagonist has been recently used as gargle and found to attenuate POST more significantly than ketamine.This comparison has been made in patients in whom airway was secured using endotracheal tube. Our study was aimed at assessing and comparing the efficacy of magnesium sulphate and ketamine gargles on incidence and severity of post-operative sore throat following endotracheal intubation. 
Close