A study aimed to evaluate and compare the effect of nebulisation with two different doses of fluticasone drug before starting anaesthesia, on the occurrence and severity of sore throat (throat pain) in patients undergoing general anaesthesia with endotracheal tube.
- Registration Number
- CTRI/2020/05/024987
- Lead Sponsor
- Naresh Kumar Gautam
- Brief Summary
Different studies have shown that preoperativenebulization with budesonide in a dose of400mcg per day is effective for attenuating POST.However, there isonly one study where preoperative nebulisation with fluticasone in a dose of 500mcg was found to be efficacious inprevention of POST. As Fluticasone is twice as efficacious as Budesonide[14], we hypothesise that pre-operative nebulization with250mcg of Fluticasone will be equally effective in reducing the incidence andseverity of POST. In this study we aim to compare the efficacy ofpre-operative nebulisation of 250mcg offluticasone with 500mcg fluticasone and normal saline in reduction ofincidence and severity of POST in adult patients following endotracheal intubation under generalanaesthesia. These doses are shown to be not associated withhypothalamo-pituitary-adrenal axis depression even iftaken for 10 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 120
AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS 1 AND 2 UNDERGOING LAPAROSCOPIC SURGERIES.
- Patient with anticipated difficult airway.
- Patients with history of preoperative sore throat, oral surgeries, asthma, COPD, diabetes, head and neck surgeries.
- 3.Patients with known allergies to study drugs and rescue drugs.
- Patients consuming NSAIDS and steroidal drugs.
- Duration of surgery less than 1 or more than 4 hours.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence and Severity of Post Operative Sore Throat. 0,2,6,12,24 hours after Extubation.
- Secondary Outcome Measures
Name Time Method 1. Incidence and severity of cough. 2. Incidence and severity of hoarseness of voice.
Trial Locations
- Locations (1)
Vardhman Mahavir Medical College and Safdarjung Hospital
🇮🇳South, DELHI, India
Vardhman Mahavir Medical College and Safdarjung Hospital🇮🇳South, DELHI, IndiaNaresh Kumar GautamPrincipal investigator8076370174doctornakul04@gmail.com