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CTRI Number  CTRI/2025/04/083883 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   “Comparison of nebulized ketamine with nebulized magnesium sulphate on the incidence of post operative sore throat.” 
Scientific Title of Study   Comparison of nebulized ketamine with nebulized magnesium sulphate on the incidence of post operative sore throat 
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 Divya Gosai 
Designation  Postgraduate resident in anaesthesiology 
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India

Ahmadabad
GUJARAT
380016
India 
Phone  9664956732  
Fax    
Email  gosaid51@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Trupti Shah 
Designation  Professor(H.G) 
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India

Ahmadabad
GUJARAT
380016
India 
Phone  9427012116  
Fax    
Email  drtrupti1968@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Trupti Shah 
Designation  Professor(H.G) 
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India

Ahmadabad
GUJARAT
380016
India 
Phone  9427012116  
Fax    
Email  drtrupti1968@gmail.com   
 
Source of Monetary or Material Support  
B.J.Medical College and Civil Hospital , Government of Gujurat 
 
Primary Sponsor  
Name  Government of Gujurat 
Address  7 th floor, Health and family welfare department , Sachivalay, Gandhinagar 
Type of Sponsor  Government 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 Divya Gosai  B.J.Medical College and Civil Hospital , Ahmedabad  Department of anaesthesia, Room number O3 , third floor, Pediatric surgery operation theatre, 1200 bed hospital, Asarwa, Ahmedabad 380016 Ahmadabad GUJARAT
Ahmadabad
GUJARAT 		 9664956732

gosaid51@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee , B.J.Medical College and Civil Hiospital , Ahmedabad  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 with Magnesium sulphate 250 mg (0.5 ml) +3.5 ml NS=4 ml   Nebulization with Magnesium sulphate 250 mg(0.5 ml) for 10 to 15 minutes preoperative before 10 to 15 minutes of induction to assess incidence of post operative sore throat in 24 hrs. 
Intervention  NEBULIZATION OF Ketamine (50 mg)+ 3 ml NS=4 ml   Nebulization with ketamine 50 mg(1 ml) for 10 to 15 minutes preoperative before 10 to 15 minutes of induction to assess incidence of post operative sore throat in 24 hrs. 
Comparator Agent  Nebulization with 4 ml Normal saline (0.9%)  Nebulization with normal saline (4 ml) for 10 to 15 minutes preoperative before 10 to 15 minutes of induction to assess incidence of post operative sore throat in 24 hrs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  o ASA grade I & II .
o Patients weight 40-70kg of either sex. o Patients scheduled for elective surgery for 120 minutes to 150 minutes under general anaesthesia requiring endotracheal intubation.  
 
ExclusionCriteria 
Details  o ASA grade III, IV , V o Patient refusing to give consent. o Pre-existing upper respiratory tract infection and anticipated difficult airway. o Surgery involving oral cavity, nasopharynx, larynx and neck region and requiring prone position. o Immunocompromised patients. o Patients with a history of allergy to the drugs to be used. o Patient requiring oral nasogastric tube insertion. o Patients undergoing laparoscopic surgery.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of POST(Post operative sore throat)  To compare the incidence of POST(Post operative sore throat) 24 hours post operative 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic changes and other side effects .  24 hrs post operative 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   12/04/2025 
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 is still a major complaint despite all the efforts made over years in patients undergoing gernal anesthesia.Various pharmacological and non pharmacological trials have been used  to decrease the incidence of post operative sore throat. It is known that NMDA receptors have role in nociception and inflammation. Antinociceptive and antiinflammatory property of ketamine and magnesium sulfate  suggest that both have potential role in reducing post operative sore throat. 
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