PloS one
The combination of simethicone and N-acetylcysteine in lidocaine ice popsicle compared with lidocaine ice popsicle alone in patients undergoing unsedated esophagogastroduodenoscopy: A prospective double-blind randomized controlled trial
By Intarasangkhanawin P, Orrapin S, Anuponganan W and 2 others.
Abstract
Background
Optimal mucosal visualization is essential for high-quality esophagogastroduodenoscopy (EGD), particularly for the detection of subtle upper gastrointestinal lesions. Oral simethicone and N-acetylcysteine (NAC) are commonly used to improve mucosal cleanliness, whereas lidocaine ice popsicles provide effective topical pharyngeal anesthesia for unsedated EGD. We evaluated whether incorporating simethicone and NAC into a lidocaine ice popsicle could improve mucosal visibility while maintaining patient comfort.
Methods
This single-center, prospective, double-blind, randomized controlled trial enrolled 374 adults undergoing unsedated diagnostic EGD between December 2024 and June 2025. Participants were randomized (1:1) to receive either a lidocaine ice popsicle containing simethicone (100 mg) and NAC (600 mg) or a conventional lidocaine ice popsicle. The primary outcome was mucosal visibility assessed using a modified Total Visibility Score (TVS). Secondary outcomes included procedure time, water volume required for mucosal cleansing, additional simethicone use, endoscopist satisfaction, ease of esophageal instrumentation, gag reflex, patient satisfaction, discomfort, pain, and adverse events. Statistical analyses were performed using SPSS version 25.0 (IBM Corp., Armonk, NY, USA).