Comparative evaluation of preoperative nebulization with two doses of budesonide for post operative sore throat following endotracheal intubation under general anaesthesia

Post-operativesore throat (POST) is an unavoidable outcome of general anaesthesia followingendotracheal intubation that affects up to 62% of patients undergoing general anaesthesia. It occurs because of aseptic inflammatory process caused by irritation of thepharyngeal mucosa during laryngoscopy and tracheal mucosa by cuff ofendotracheal 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 withoutspecific treatment. However, in moderate to severe cases, it may require treatmentfor pain and dysphagia.

Theaetiology of POST is multifactorial. It includes patient-related factors suchas age, sex, smoking and intubationfactors including time and manipulations needed to insert thetube, duration for which the tube is in place, tube size, intra-cuffpressure, cuff design, intraoperative tube movementandsuctioning.

Variousnon-pharmacological and pharmacological methods have been used for attenuatingPOST with varying efficacy. The non-pharmacological methods include smallersize endotracheal tubes, lubricating the endotracheal tube with water solublejelly, careful airway instrumentation, intubating after full relaxation, gentleoesophageal suctioning, minimizing intra-cuff pressure and extubation when thetracheal cuff is fully deflated. The pharmacological methodsinclude pre-operative gargling and nebulization with various agents likeketamine, local anaesthetics, budesonide,beclomethasone and azulene sulphonate etc. Steroids are well known for their anti-inflammatoryfunction. They are widely used in clinic. The inhaled corticosteroids (ICSs),like budesonide and fluticasone, are widely used for patients at risk of airwaydiseases (i.e., asthma, chronic obstructive pulmonary disease (COPD) and acutepharyngitis) due to its high efficacy in controlling and preventing symptomsymptoms with reduced systemic side effects since it can be directly deliveredto the airways without introducing a systemic exposure. The beneficialproperties of ICS include low oral bioavailability, high systemic clearance,and sufficient receptor binding affinity. Since ICS inhalation possesses thesebeneficial properties, it has been considered a more secure treatment. Budesonidehas been used in doses as high as 500 microgram given twice daily (1mg per day)through nebulized form for 10 consecutive days. It showed nohypothalamo-pituitary-adrenal-axis suppression. This proves the safety of thestudy drug.

Previousstudies have reported different protocols in terms of number of times budesonideis administered, varying from a single preoperative dosage to multiplenebulisation

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

Inthis study we aim to compare the efficacy of pre-operative nebulisation with250 microgram of budesonide versus 500 microgram and normal saline in reductionof incidence and severity of POST in adult patients following endotrachealintubation under general anaesthesia undergoing laproscopic surgery.