To compare the effect of budesonide inhaler with nebuliser in postoperative sore throat

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/07/055651
• Lead Sponsor: Pt B D Sharma University of Health Sciences PGIMS, Rohtak, Haryana

Brief Summary

A prospective, comparative, randomised and unblinded study will be conducted in patients of either sex of age 18-60 years ,belonging to American Society of Anesthesiologists (ASA) physical status of I-II with mallampati grading of I-II undergoing surgeries under general anaesthesia.Patients with anticipated difficult airway,history of allergic to test drug ,active preoperative sore throat, analgesics and corticosteroids (inhaled or systemic) in treatment regime, history of fluid retention, history of delayed wound healing, history of glucose intolerance, patients undergoing laparoscopic surgeries, duration of surgery less than 60min or more than 180min, refusal to participate in the study will be excluded from the study.Patients will be randomly allotted to one of the two groups according to computer generated list. Group I will recieve 200mcg budesonide inhalation suspension 30min before Intubation which will be repeated 6hrs after extubation and group N will recieve 0.5mg of budesonide respule via nebulisation 30min before intubation which will be repeated 6hrs after the extubation. Postoperative sore throat grade and postoperative hoarseness of voice grade will be noted at 2hr, 6hr, 24hr post extubation. Data will be analysed using appropriate statistical methods.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-08
• Study Start: 2023-08-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients belonging to ASA 1-2 with MPG 1-2 undergoing surgery under general anaesthesia.

Exclusion Criteria

Patients with anticipated difficult airway, history of allergy to test drug,active preoperative sore throat,analgesics and corticosteroids in treatment regime,history of fluid retention, history of delayed wound healing, history of glucose intolerance,laparoscopic surgeries ,duration of surgery < 60min or >180min, refusal to participate in the study will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of inhaled budesonide suspension with metered dose inhaler and nebulisation on severity of sore throat at an intervals of 0hrs, 6hrs, 24hrs postoperatively	To compare the effect of inhaled budesonide suspension with metered dose inhaler and nebulisation on severity of sore throat at an intervals of 0hrs, 6hrs, 24hrs postoperatively

Secondary Outcome Measures

Name	Time	Method
For postoperative sore throat subsequent to endotracheal intubation	For postoperative sore throat subsequent to endotracheal intubation

Trial Locations

Locations (1)

Pt B D Sharma PGIMS,Rohtak; 🇮🇳 Rohtak, HARYANA, India

Pt B D Sharma PGIMS,Rohtak

🇮🇳Rohtak, HARYANA, India

Dr Akshay Jaswal

Principal investigator

7973339709

akshayjaswal1@gmail.com