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CTRI Number  CTRI/2025/09/094760 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 14/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To Study the Comparison of the Effects of Ketamine or Magnesium Sulphate Spray on the Incidence and Severity of Sore Throat Experienced after Surgery. 
Scientific Title of Study   A Randomised Clinical Trial Comparing the Impacts of Magnesium Sulphate and Ketamine Spray on the Incidence and Severity of Sore Throat following intubation in Patients Under General Anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JENIN HERBERT 
Designation  Post Graduate Registrar 
Affiliation  Christian Medical College 
Address  Department Of Aneasthesia Christian Medical College
Department Of Aneasthesia Christian Medical College
Vellore
TAMIL NADU
632004
India 
Phone  9150522079  
Fax    
Email  jeninherbert@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  EKTA RAI 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department Of Aneasthesia Christian Medical College
Department Of Aneasthesia Christian Medical College
Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  EKTA RAI 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department Of Aneasthesia Christian Medical College
Department Of Aneasthesia Christian Medical College
Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Source of Monetary or Material Support  
CHRISTIAN MEDICAL COLLEGE VELLORE 
 
Primary Sponsor  
Name  CHRISTIAN MEDICAL COLLEGE 
Address  CHRISTIAN MEDICAL COLLEGE VELLORE 
Type of Sponsor  Private 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 
DR JENIN HERBERT  CHRISTIAN MEDICAL COLLEGE HOSPITAL  OPERATING ROOMS DEPARTMENT OF ANESTHESIA CHRISTIAN MEDICAL COLLEGE
Vellore
TAMIL NADU 
09150522079

jeninherbert@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL REVIEW BOARD SILVER ETHICS AND RESEARCH COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, (2) ICD-10 Condition: N219||Calculus of lower urinary tract, unspecified, (3) ICD-10 Condition: C154||Malignant neoplasm of middle thirdof esophagus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ketamine  Ketamine spray 0.5 mg/kg is administered using a Magik atomiser in the oral cavity at the uvula tonsils posterior pharyngeal wall vallecula and between vocal cords during laryngoscopy before intubation 
Intervention  magnesium sulphate   magnesium spray 30MG PER KG is administered using a Magik atomiser in the oral cavity at the uvula tonsils posterior pharyngeal wall vallecula and between vocal cords during laryngoscopy before intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age 18 years to 60 years
2. Elective surgeries
3. ASA classes 1,2, and 3
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Allergic to the study drugs
3. Anticipated difficult airway
4. Emergency surgeries
5. Head and neck surgeries.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of magnesium and ketamine spray in reducing the incidence and severity of postoperative sore throat.   five time intervals: 30-minute,1,6,12, and 24 hours after extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
: To compare the effectiveness of magnesium and ketamine spray in reducing the incidence and severity of cough, dysphagia, and hoarseness  five time intervals: 30 minutes, 1,6, 12, and 24 hours after extubation. 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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 1 
Date of First Enrollment (India)   30/09/2025 
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="1"
Months="0"
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  

Post-operative sore throat refers to irritation or pain in the throat that occurs within 15 minutes to 24 hours after the extubation phase. The incidence of POST has been estimated to range from 6.6% to 90% following tracheal intubation, while the incidence is lower after LMA insertion (17.5%).  POST is one of the major causes of patient dissatisfaction and discharge delays following ambulatory surgery. Routine tracheal intubation for elective surgical procedures can lead to pathological changes, trauma, and nerve damage, which may contribute to postoperative throat symptoms. Various medications, including ketamine, lidocaine, budesonide, dexamethasone, and magnesium sulphate, have been administered via nebulisation, gargling, or intravenous routes to alleviate this issue in different institutions.

While numerous protocols have been proposed to prevent post-operative sore throat (POST), few have attracted significant interest. Various pharmacological and nonpharmacological methods have been explored to decrease POST incidence. Standard treatments include multimodal analgesia and adjuncts such as NSAIDs, lidocaine, and beclomethasone. Additionally, ketamine and magnesium sulphate gargles, as well as nebulization, have been tested, as these substances inhibit the N-methyl-D-aspartic acid receptor without providing direct analgesic effects. Research highlights the influence of factors like endotracheal tube size and cuff pressure on POST, yet literature on the effects of ketamine and magnesium sulphate aerosol is limited. This study aims to compare the impact of ketamine and magnesium sulphate atomizer spray on the occurrence of POST in adult patients undergoing general anaesthesia with endotracheal intubation. The study’s objective is to assess both the incidence of POST and the influence of these atomizer sprays on hemodynamic parameters.

 
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