A comparative, open-label, randomized study of efficacy and tolerability of nasal irrigation with budesonide-enhanced ringer’s lactate versus ringer’s lactate alone in post functional endoscopic sinus surgery with chronic rhinosinusitis

1. It is a prospective, comparative, open-label, randomized control study that will be conducted in the Otorhinolaryngology department of KIMS hospital, Bangalore for a period of 1.5 years.

2. Subjects will be recruited based on inclusion and exclusion criteria after getting approval from Institutional Ethics Committee (IEC).

3. The written informed consent will be obtained from all the study subjects after being satisfactorily informed about the study’s methodology.

4. Demographic data and relevant medical history will be obtained from all the study subjects.

5. Relevant examinations and baseline investigations are done pre-operatively (visit 0). SNOT-22 (Sino-Nasal Outcome Test–22) questionnaire will be administered to the study subjects by the investigator through a direct interview, during which the study subjects will be asked each question, and their responses will be recorded accordingly. Lund Kennedy Endoscopic (LKE) score will be assessed by the investigator. The HRQL based on RSDI (Rhino Sinusitis Disability Index) will also be documented.

6. Based on simple randomization in a 1:1 allocation, subjects (n = 100) will be split into two groups (50 in each) after the FESS operation: Interventions:

GROUP A (n=50): Ringer’s lactate nasal irrigation enhanced with budesonide. Budesonide solution (Budesonide respules used for irrigation): 0.5mg/2mL respules. 1 mg budesonide (2 respules) in 500ml Ringer’s lactate per day. 40mL of the prepared solution is used per session twice daily (morning and evening) for 6 weeks, 20mL for each side of the nose per session.

GROUP B (n=50): Ringer’s lactate solution for nasal irrigation.

1. Sino-Nasal Outcome Test (SNOT-22)

2. Lund-Kennedy Endoscopic Score (LKE Score)

3. Rhinosinusitis Disability Index (RSDI)

Ringer’s lactate solution (0.9%). 40mL of Ringer’s Lactate per session twice daily (morning and evening) for 6 weeks, 20mL for each side of the nose per session. DEVICE:  A 20cc sterile syringe is used to deliver the irrigation solution into each nostril with controlled pressure.

ADMINISTRATION: Two budesonide (0.5mg/2mL each) respules are mixed in 500mL of Ringer’s Lactate. • 20mL of this solution is instilled into each nostril per session using the syringe, twice daily.

The patient should lean forward, tilt the head sideways, and allow the solution to exit through the opposite nostril.