1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [gargankush27@gmail.com].
   


6. For how long will this data be available start date provided 15-09-2021 and end date provided 01-09-2022?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Post-operative sore throat (POST) is an unavoidable outcome of general anaesthesia following endotracheal intubation that affects up to 62% of patients undergoing general anaesthesia. It occurs because of aseptic inflammatory process caused by irritation of the pharyngeal mucosa during laryngoscopy and tracheal mucosa by cuff of endotracheal tube. It leads to patient’s distress and dissatisfaction. Complaints of patients include minor throat irritation, inability to swallow, hoarseness of voice and cough. In most cases it resolves spontaneously without specific treatment. However, in moderate to severe cases, it may require treatment for pain and dysphagia.

The aetiology of POST is multifactorial. It includes patient-related factors such as age, sex, smoking and intubation factors including time and manipulations needed to insert the tube, duration for which the tube is in place, tube size, intra-cuff pressure, cuff design, intraoperative tube movement and suctioning.

Various non-pharmacological and pharmacological methods have been used for attenuating POST with varying efficacy. The non-pharmacological methods include smaller size endotracheal tubes, lubricating the endotracheal tube with water soluble jelly, careful airway instrumentation, intubating after full relaxation, gentle oesophageal suctioning, minimizing intra-cuff pressure and extubation when the tracheal cuff is fully deflated. The pharmacological methods include pre-operative gargling and nebulization with various agents like ketamine, local anaesthetics, budesonide, beclomethasone and azulene sulphonate etc. Steroids are well known for their anti-inflammatory function. They are widely used in clinic. The inhaled corticosteroids (ICSs), like budesonide and fluticasone, are widely used for patients at risk of airway diseases (i.e., asthma, chronic obstructive pulmonary disease (COPD) and acute pharyngitis) due to its high efficacy in controlling and preventing symptom symptoms with reduced systemic side effects since it can be directly delivered to the airways without introducing a systemic exposure. The beneficial properties of ICS include low oral bioavailability, high systemic clearance, and sufficient receptor binding affinity. Since ICS inhalation possesses these beneficial properties, it has been considered a more secure treatment. Budesonide has been used in doses as high as 500 microgram given twice daily (1mg per day) through nebulized form for 10 consecutive days. It showed no hypothalamo-pituitary-adrenal-axis suppression. This proves the safety of the study drug.

Previous studies have reported different protocols in terms of number of times budesonide is administered, varying from a single preoperative dosage to multiple nebulisation

Total dose of budesonide used in these studies has varied from 200 microgram preoperatively to 1 milligram given in multiple divided doses, but it has been found that single pre-operative dosage is more efficacious than multiple nebulisation for preventing POST.

In this study we aim to compare the efficacy of pre-operative nebulisation with 250 microgram of budesonide versus 500 microgram and normal saline in reduction of incidence and severity of POST in adult patients following endotracheal intubation under general anaesthesia undergoing laproscopic surgery.