Comparative evaluation of preoperative nebulization with two doses of budesonide for post operative sore throat following endotracheal intubation under general anaesthesia
- Conditions
- Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, (3) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis,
- Registration Number
- CTRI/2021/07/035159
- Lead Sponsor
- Ankush Garg
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 105
Belonging to American society of Anaesthesiologists (ASA) physical status I and II undergoing laparoscopic surgery under general anaesthesia with endotracheal intubation.
- 1)Patients with difficult airway 2)Patients with a history of pre-operative sore throat, oral surgeries, asthma, diabetes, chronic obstructive pulmonary disease, head and neck surgeries.
- 3)Patient with known allergies to study drug and rescue drugs.
- 4)Patients consuming non-steroidal anti-inflammatory drugs within 24 hours prior to the surgery or on systemic or topical steroid therapy or having taken steroid drugs within five days prior to the surgery.
- 5)Duration of surgery > 1 hour and < 4 hours.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and severity of Postoperative sore throat 0, 6, 12, 24 hours after extubation
- Secondary Outcome Measures
Name Time Method Incidence of cough and hoarseness of voice 0, 6, 12, 24 hours after extubation
Trial Locations
- Locations (1)
Vardhman Mahavir Medical College and Safdarjung Hospital
🇮🇳South, DELHI, India
Vardhman Mahavir Medical College and Safdarjung Hospital🇮🇳South, DELHI, IndiaAnkush GargPrincipal investigator9871281610gargankush27@gmail.com