Comparison of preoperative budesonide and saline nebulisation in reducing the incidence of postoperative sore throat in patients undergoing general anaesthesia with endotracheal intubation-A randomised controlled trial

This study is to compare  the  effectivenss of nebulisation budesonide to that  of saline  in reducing the incidence of Postoperative sore throat (POST)

A Randomised controlled trial will be conducted over a period of 1 year and 6 months on 96 patients of ASA I-II status,in the age group 20-60 years undergoing elective surgery requiring GA with endotracheal intubation.All patients will be subjected to a thorough pre anaesthetic evaluation, the study will be explained in detail and written informed consent will be obtained.

Patients enrolled for study will be randomised into two groups of 48 each,using computer generated random number tables in opaque sealed envelopes.The envelopes will be  opened by a circulating nurse not involved in the study. Preoperative nebulisation will be given  to the groups 15 minutes prior to the induction of anaesthesia as follows

Group B-Neb.Budesonide 1ml(250 mcg)

with 4ml normal saline(5ml)

Group S-Neb.Normal saline (5ml)

Patient will be induced with Injection Fentanyl 1-2 mcg/kg body weight, Propofol 1.5-2mg/kg and Rocuronium 1mg/kg. Direct laryngoscopy and  tracheal intubation will  be done  with  a sterile  soft seal polyvinylchloride  cuffed endotracheal tube. The tracheal cuff pressure will be maintained between 20-25cm of H2O. Anaesthesia will be maintained with oxygen, air and sevoflurane.

On completion of surgery, patients will be extubated and transferred to PACU. Incidence and severity of sore throat,incidence of cough and hoarsenss of voice will be assessed based on the scales provided in table 1 of the annexure at 0hr, 2hrs,4hrs,24hrs. Data will be summarised by using descriptive statistics.