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CTRI Number  CTRI/2023/09/057713 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 05/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the efficacy of preoperative nebulization with magnesium sulfate and normal saline in reducing the incidence of postoperative sorethroat following tracheal intubation in patients receiving general anaesthesia 
Scientific Title of Study   Effect of Magnesium Sulfate nebulisation on incidence of postoperative sorethroat; A Randomized prospective double blinded study 
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 Priyadharshini E U 
Designation  Junior Resident Academic 
Affiliation  Rajendra Institute of Medical Sciences, Ranchi 
Address  Department of Anaesthesiology, RIMS, Bariatu, Ranchi - 834009, Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  9597012289  
Fax    
Email  eupriyadharshini97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dipali Singh 
Designation  Addititonal Professor 
Affiliation  Rajendra Institute of Medical Sciences, Ranchi 
Address  Department of Anaesthesiology, RIMS, Bariatu, Ranchi - 834009, Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  9620310511  
Fax    
Email  dipalishio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manisha Bhagat 
Designation  Assistant Professor 
Affiliation  Rajendra Institute of Medical Sciences, Ranchi 
Address  Department of Anaesthesiology, RIMS, Bariatu, Ranchi - 834009, Jharkhand

Ranchi
JHARKHAND
834009
India 
Phone  9386269477  
Fax    
Email  bhagatmanisha7@gmail.com  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences,Ranchi,Bariatu,Ranchi,Jharkhand 834009 
 
Primary Sponsor  
Name  Rajendra Institute of Medical Sciences Ranchi 
Address  Bariatu,Ranchi,Jharkhand 834009 
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 Priyadharshini E U  Rajendra Institute of Medical Sciences Ranchi  Surgery OT, 3rd Floor, Old Building, Rajendra Institute of Medical Sciences,Ranchi,Bariatu,Ranchi Jharkhand 834009
Ranchi
JHARKHAND 
9597012289

eupriyadharshini97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Rajendra Institute of Medical Sciences, Ranchi  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 
Intervention  Magnesium Sulfate  Pre induction nebulization with magnesium sulfate 250 mg in 3ml of normal saline over 15 minutes before intubation. 
Comparator Agent  Normal Saline  Pre induction nebulization with 3ml of 0.9% normal saline over 15 minutes before intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I and II
Duration of surgery being less than 2 hours 
 
ExclusionCriteria 
Details  ASA grade III & IV

Age <18years and >60 years

Pregnant patient

Refusal of consent for procedure

Allergy or hypersensitivity to magnesium drugs

Pateints undergoing ENT,dental,neck surgeries

Procedures lasting for more than 2 hours

Patients having pre-operative sore throat,cough,hoarseness of voice

Patients receiving IV/ Nebulisation with steroids

Patients having anticipated difficult airway(Mallampati III & IV 
 
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 
To compare the efficacy of preoperative nebulization with magnesium sulfate 250mg in 3ml of normal saline versus 3ml of 0.9% normal saline in reducing the incidence of post operative sore throat following tracheal intubation with endotracheal tube in patients receiving general anaesthesia.  Before induction.

at 0 hour of immediate extubation.

at 4th hour post op

at 8th hour post op

at 12th hour post op

at 24th hour post op

at 48th hour post op 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the reduction in the incidence of cough & hoarseness of voice following nebulization with magnesium sulfate and normal saline in the post operative period.  Before induction.

at 0 hour of immediate extubation.

at 4th hour post op

at 8th hour post op

at 12th hour post op

at 24th hour post op

at 48th hour post op 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   18/09/2023 
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  

Sore throat is a common complication in post operative period after tracheal intubation, and one of the most common undesirable anaesthesia associated problems. The incidence of post operative sore throat (POST) has been found to be as high as 21% - 65%. The factors known for post operative sore throat include age, sex, larger tracheal tubes, cuff design, intracuff pressures, mechanical injury during laryngoscopy and intubation, continuous pressure by the inflated tracheal tube cuff on tracheal mucosa causing injury and dryness of the mucosa. The use of Nitrous oxide also increases incidence of post operative sore throat. 

Thus various measures has been attempted to reduce the incidence of POST- Some among these are non pharmacological and some pharmacological. Gentle endotracheal intubation for elective surgeries in a single attempt with avoidance of inadvertent trauma to the airway accounts for minimal incidence of sore throat. Awareness and knowledge about the potential risk factors and precautions may thereby help to reduce this complication. These factors include avoidance of large endotracheal tubes, careful airway instrumentation, decreasing the number of attempts of both laryngoscopy and intubation, intubation after full relaxation of larynx, gentle oropharyngeal suctioning and extubation when the tracheal tube is fully deflated. Besides inflating the bulb of endotracheal tube to a pressure <20mmHg and regular checking of cuff pressure also reduces post operative sore throat.

 

Pre-emptive application of locally active analgesic and anti inflammatory agents can presumably decrease the discomfort, airway inflammation and in turn sore throat. Pharmacological measures include inhalation of beclomethasone and fluticasone, gargling with azulene sulfonate, aspirin, benzydamine hydrochloride and licorice, ketamine as gargle or nebulization, intracuff application of alkalized lignocaine and application of lignocaine spray.

It is an established fact that NMDA receptors (N- methyl D- aspartate) play a role in nociception and inflammation and these receptors are known to be present in central and peripheral nervous system. NMDA antagonists such as magnesium sulfate and ketamine work on peripheral nerve endings in the mucosal lining of the upper airway which in turn may reduce the incidence of sore throat. Moreover magnesium sulfate being an antagonist to NMDA receptors  further prevents sensitization to the peripheral pain stimulus.

Various studies have used magnesium sulfate in the form of nebulization in various doses. Nebulization is considered better than other methods as it is easy to administer, smaller volume of drugs with low systemic adverse effects are delivered and better acceptance forpatients may be achieved .

 With this background the present study was planned to evaluate the efficacy of preoperative magnesium sulfate nebulization to reduce the incidence of post operative sore throat in patients undergoing elective surgeries with general anaesthesia with endotracheal intubation.

 
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