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CTRI Number  CTRI/2024/07/070364 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 17/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of ketamine and magnesium sulfate nebulization to prevent sore throat after surgery in patients undergoing general anaesthesia. 
Scientific Title of Study   A comparative evaluation of nebulized ketamine and nebulized magnesium sulfate for attenuating the post operative sore throat in patients undergoing surgery under general anaesthesia: A double blinded randomized clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
17  Protocol Number 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prem Kumar P 
Designation  Post graduate trainee  
Affiliation  Regional Institute of Medical Sciences Imphal Manipur 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal

Imphal West
MANIPUR
795004
India 
Phone  9677675822  
Fax    
Email  prempalani1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  L Pradipkumar Singh 
Designation  Professor  
Affiliation  Regional Institute of Medical Sciences Imphal Manipur 
Address  Department of Anaesthesiology Regional Institute of Medical Sciences Imphal

Imphal West
MANIPUR
795004
India 
Phone  7005238251  
Fax    
Email  drlaithangba@gmail.com  
 
Details of Contact Person
Public Query
 
Name  L Pradipkumar Singh 
Designation  Professor  
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal

Imphal West
MANIPUR
795004
India 
Phone  7005238251  
Fax    
Email  drlaithangba@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur 
 
Primary Sponsor  
Name  Prem Kumar P 
Address  Regional Institute of Medical Sciences, Imphal, Manipur-795004 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
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 PREM KUMAR P  Regional Institute of Medical Sciences, Imphal west, Manipur   Elective surgery Operation Theatre complex (OT 1-9), Department of Anaesthesiology, Regional Institute of Medical Sciences
Imphal West
MANIPUR 
9677675822

prempalani1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, Regional Institute of Medical Sciences, Imphal, Manipur   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  Nebulization of 250mg Magnesium Sulfate in 5ml Normal saline in pre operative room  Study participants will be randomized into two groups. Intervention group receiving Nebulization of 250mg Magnesium Sulfate in 5ml Normal saline in pre operative room before 15 minutes of pre medication. 
Intervention  Nebulization of 50mg Ketamine in 5ml normal saline in pre operative room  Study participants will be randomized into two groups. Intervention group receiving Nebulization of 50mg Ketamine in 5ml Normal saline in pre operative room before 15 minutes of pre medication. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either sex.
2. Patients of age group 18 to 65 years.
3. Patients of American Society of Anaesthesiologists (ASA) Physical grade I or II. 
 
ExclusionCriteria 
Details  1. Patients with history of post operative sore throat.
2. Patients with history of recent respiratory tract infection.
3. Patients with history of chronic obstructive pulmonary disease, asthma, head and neck surgery.
4. Patients with inserted nasogastric tube.
5. History of allergy to study drugs and recent NSAIDs medication and steroids.
6. Patient unwillingness/ refusal. 
 
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 
post operative sore throat  Outcome will be assessed in post operative period at 0,2,4 hours  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="142"
Sample Size from India="142" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="144" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2024 
Date of Study Completion (India) 15/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

Despite the emergence of new airway devices in the recent years, rigid laryngoscopy and tracheal intubation still remains the gold standard in airway management. Tracheal intubation is a commonly used technique in general anaesthesia, but it can cause a few side effects, including sore throat and hoarseness. These symptoms, known as postoperative sore throat (POST) which occurs in 21–65% of patients receiving general anaesthesia (GA) with tracheal intubation. POST had been rated by patients as the eighth most adverse effect in the postoperative period. Although POST is a minor side effect and is self-limiting, it causes a great deal of patient dissatisfaction. So prophylactic management of POST is recommended to improve the quality of post- anaesthesia care, though the symptoms resolve spontaneously without any treatment in most of the cases.

A previously studies had shown comparison between magnesium and ketamine gargle efficacy in decreasing the incidence of POST, but nebulization is superior to gargle. In this study we compare the effect of Nebulized Ketamine and Nebulized Magnesium sulphate to prevent Post operative sore throat.

This study will be prospective, double blinded randomized clinical trial to compare the effects of Nebulized ketamine versus Nebulized Magnesium sulfate for the Prevention of Post operative sore throat. A total of 142 patients of either sex will be selected for the study and divided into 2 groups Group K will receive Nebulization of ketamine 50mg in 5ml Normal saline and Group M will receive Nebulization of Magnesium sulphate 250mg in 5ml Normal saline. The patients will be looked for Post operative sore throat and if present, will be scored as 0 = No sore throat, 1 = Mild sore throat, 2 = Moderate sore throat, 3 = Severe sore throat. The data will be entered in SPSS version 26.0 and analysed using ANOVA test or Pearson Chisquare test as where appropriate.

 
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