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CTRI Number  CTRI/2022/02/040289 [Registered on: 14/02/2022] Trial Registered Prospectively
Last Modified On: 13/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Use of two drugs taken through nose via special device before operation (nebulisation) for prevention of sorethroat which may occur in postoperative period due to insertion of a tube in windpipe. 
Scientific Title of Study   Preoperative nebulization with Magnesium sulfate versus Ketamine for prevention of endotracheal tube induced postoperative sore throat-A prospective,randomized,comparative clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Darshna Dharmendra Patel 
Designation  Assistant Professor 
Affiliation  Govt Medical College,SSG Hospital,Vadodara 
Address  202,VAIDEHI RESIDENCY 44/1,ARUNODAY SOCIETY, ALKAPURI, VADODARA-390007 , Vadodara GUJARAT 390007 INDIA

Vadodara
GUJARAT
390007
India 
Phone  9925013155  
Fax    
Email  dr.darshna1968@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Darshna Dharmendra Patel 
Designation  Assistant Professor 
Affiliation  Govt Medical College,SSG Hospital,Vadodara 
Address  202,VAIDEHI RESIDENCY 44/1,ARUNODAY SOCIETY, ALKAPURI, VADODARA-390007 , Vadodara GUJARAT 390007 INDIA

Vadodara
GUJARAT
390007
India 
Phone  9925013155  
Fax    
Email  dr.darshna1968@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyankaben Patel  
Designation  Student  
Affiliation  Govt Medical College,SSG Hospital,Vadodara 
Address  83, new RMO hostel. Opposite to ssg hospital campus Jail road Raopura :390001 Vadodara

Vadodara
GUJARAT
390001
India 
Phone  7874260593  
Fax    
Email  patelpj1995@gmail.com  
 
Source of Monetary or Material Support  
SSG Hospital,Vadodara 
 
Primary Sponsor  
Name  SSG Hospital Vadodara 
Address  Govt Medical College,SSG Hospital,Jail Road,Vadodara 
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 Darshna Dharmendra Patel  SSG Hospital  Dept of Anaesthesiology Government Medical College, Jail Road, Vadodara Vadodara GUJARAT Vadodara
Vadodara
GUJARAT 		 9925013155

dr.darshna1968@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee for biomedical and health research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ketamine  Patients nebulised with Ketamine 50 mg(1 ml) in 4ml of normal saline over 15-20 minutes once before induction on the day of surgery  
Intervention  Magnesium sulfate  Patients nebulised with Magnesium 250 mg(1ml) in 4 ml of normal saline over 15-20minutes once before induction on the day of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective surgery under General anaesthesia requiring intubation and expected to last for less than three hours
2.ASA status I, II,III
3.Mallampatti airway assessment of Grade I and II.

 
 
ExclusionCriteria 
Details  1)Patients who refuse to give consent
2)Anticipated difficult airway or Mallampatti Grade III & IV
3)Preoperative sore throat.
4)Active upper respiratory tract infections
5)Procedures requiring perioperative nasogastric tube placement or throat packing.
6)Patients with a high risk of aspiration.
7)Surgery involving oral cavity,nasopharynx, larynx or neck region
8)History of allergies/ bronchial asthma/ Chronic obstructive pulmonary disease
9)Surgery in prone position
10)Pregnant women.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence and severity of sorethroat at 4th postoperative hour.  4th postoperative hour. 
 
Secondary Outcome  
Outcome  TimePoints 
1) To compare the incidence and severity of sorethroat at 0, 2nd,6th,12th and 24th postoperative hours
2) To compare the incidence and severity of postoperative hoarseness of voice and cough
3) To note any side effects like nausea,vomitting and dry mouth
 		 0,2,6,12 and 24 hours 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   15/02/2022 
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="8"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study will be carried out at government medical college,SSG Hospital,Vadodara. Overall purpose of this study is to compare the efficacy of nebulised ketamine versus nebulised magnesium sulfate for attenuation of postoperative sorethroat in patients undergoing general anaesthesia with endotracheal intubation. 
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