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CTRI Number  CTRI/2024/09/073844 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 12/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of aspirin and magnesium sulphate gargle for prevention of postoperative sore throat in patients undergoing lumbar laminectomy 
Scientific Title of Study   Comparative evaluation of aspirin and magnesium sulphate gargles for prevention of postoperative sore throat in patients undergoing lumbar laminectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Kundra 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia, Dayanand Medical College and Hospital,Civil lines, Ludhiana,141001 PUNJAB, INDIA

Ludhiana
PUNJAB
141001
India 
Phone  9815608241  
Fax    
Email  sandeepkundra07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Kundra 
Designation  Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Deapartment of Anaesthesia, Dayanand Medical College and Hospital,Civil lines, Ludhiana,141001 PUNJAB, INDIA


PUNJAB
141001
India 
Phone  9815608241  
Fax    
Email  sandeepkundra07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jaspal Kaur 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Deapartment of Anaesthesia, Dayanand Medical College and Hospital,Civil lines, Ludhiana,141001 PUNJAB, INDIA


PUNJAB
141001
India 
Phone  9464896232  
Fax    
Email  kkjaspal2@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital Civil Lines, Ludhiana, 141001, Punjab, India. 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital  
Address  Tagore Nagar , Civil lines, Ludhiana 141001 PUNJAB INDIA 
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 Jaspal Kaur  Dayanand Medical College and Hospital  Deapartment of Anaesthesia, Dayanand Medical College and Hospital, Civil lines, Ludhiana,141001 PUNJAB, INDIA
Ludhiana
PUNJAB 
9464896232

kkjaspal2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical committee, Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparative evaluation of aspirin and magnesium sulphate gargles for prevention of postoperative sore throat in patients undergoing lumbar laminectomy  Patients in Group A will recieve Tab ASPIRIN 325MG in 20ml of 5% dextrose for mouth gargles 15 minutes prior to 15 minutes. 
Comparator Agent  Comparative evaluation of aspirin and magnesium sulphate gargles for prevention of postoperative sore throat in patients undergoing lumbar laminectomy   Patients in Group B will recieve 2ml of Magnesium sulphate (50% w/v) in 20 ml of 5% dextrose for mouth gargles 15 minutes prior to induction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I,II,III patients posted for elective lumbar laminectomy surgery in general anesthesia 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Any known hypersenstivity or contraindication to aspirin, magnesium sulphate.
3. Recent H/O Sore throat.
4. Pregnant & lactating mothers.
5. Anticipated difficult intubation, MPS Grade III and IV.
6. Patients receiving chronic treatment with calcium channel blocking drugs or magnesium.
7. Patients on steroids due to any reason.
8. History of reactive airway disease like bronchial asthma or COPD, significant neurological or neuromuscular disorder.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Incidence of sore throat.
2.Severity of sore throat as assessed by NRS and subjective grading score. 
At 1hour,2hour,4hour,12hour and 24hours 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of post extubation cough  At 0hour,1hour,2hour,4hour,12hour and 24hour 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/09/2024 
Date of Study Completion (India) 12/03/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Postoperative sore throat (POST) is a common complication after endotracheal intubation. POST contributes to discomfort and morbidity for the patient. POST is the result of local tissue trauma due to laryngoscopy and endotracheal intubation leading to the inflammation of the pharyngeal mucosa. Aspirin is a commonly used NSAID which acts by inhibiting the prostaglandin system. Aspirin gargles have been observed to significantly reduce the incidence and severity of POST. Magnesium, an NMDA receptor antagonist in a few preliminary studies has also been seen to reduce POST. However; definitive evidence on the role of magnesium sulphate gargles for the prevention of POST is lacking. Aim of the study is to compare the efficacy of gargles with aspirin and magnesium sulphate for the prevention of postoperative sore throat in patients undergoing lumbar laminectomy in prone position.  A prospective, randomized, double blinded study will be conducted on sixty patients of either sex between age group 18 to 65 years belonging to ASA grade I, II and III scheduled for elective lumbar laminectomy under general anaesthesia. Patients will be randomly allocated to two groups –Group A and Group B of 30 patients each. Group A patients will receive gargle solution of tab Aspirin 325mg in 20ml of 5% dextrose while group B patients will receive gargle solution of 2ml Magnesium sulphate in 20ml of 5% dextrose. In Post anesthesia care unit (PACU), patients will be evaluated for incidence and severity of sore throat using Numerical Rating Scale (NRS) and severity grading scale at 1, 2, 4 and 24 hrs postoperatively. This study will aid elucidating the role of magnesium sulphate gargles for the prevention of POST.

 
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