- Design
- Single-centre, double-blind randomised controlled trial
- Population
- 374 adults undergoing unsedated diagnostic upper endoscopy, Thailand
- Primary outcome
- Mucosal visibility (modified Total Visibility Score)
- Effect
- 6.19 vs 10.39; mean difference −4.20 (95% CI −4.53 to −3.88)
This single-centre, double-blind trial in Thailand randomised 374 adults having unsedated diagnostic upper endoscopy to a lidocaine ice popsicle containing simethicone 100 mg and N-acetylcysteine 600 mg, or a standard lidocaine popsicle. All patients completed the study.
Mucosal visibility was clearly better with the combined popsicle (Total Visibility Score 6.19 vs 10.39, lower is better; difference −4.2), across all six segments. Procedures were about two minutes shorter, less water was needed for cleaning, and additional simethicone flushing was required in 12.8% against 96.8%. Endoscopists were more satisfied; patient satisfaction and comfort were similar. No adverse events occurred.
Unsedated endoscopy is common in India, and simethicone and N-acetylcysteine are cheap and widely available. Combining mucosal cleansing with pharyngeal anaesthesia in one step is a simple change that could improve views for detecting early gastric and oesophageal lesions.
- Consider adding simethicone and N-acetylcysteine to pre-endoscopy preparation for unsedated upper endoscopy.
- Give them together with topical lidocaine to keep preparation to one step.
- Expect less time spent flushing mucus and bubbles during the procedure.
- Use the clearer view to inspect carefully for early neoplasia.
Why it matters
Better views at no real cost improve the chance of catching early upper GI cancers.
Don't overread it
This was a single centre; whether clearer views increase lesion detection was not measured.
The statistics, in plain English
A difference of −4.2 points (95% CI −4.53 to −3.88) on the visibility score is large and precise. Detection of lesions, the outcome that ultimately matters, was not assessed.
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