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Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial.

  • 2023-10-18
  • Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology 43(5)
    • Zaheer Nabi
    • Mohan Vamsi
    • Rajesh Goud
    • Mahiboob Sayyed
    • Jahangeer Basha
    • Palle Manohar Reddy
    • Rithesh Reddy
    • Praveen Reddy
    • Chaithanya Manchu
    • Santosh Darisetty
    • Rajesh Gupta
    • Manu Tandan
    • Guduru Venkat Rao
    • D Nageshwar Reddy

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 800
Population
800 patients (39 years, 68.8% males)
Methods
Double-blinded (patient and investigator), randomized trial; patients randomized into four groups: A (water), B (simethicone), C (N-acetyl cysteine), D (S+NAC); premedication solutions administered 10-30 minutes before endoscopy
Blinding
Double-blind
Duration
10-30 minutes
Funding
Unclear
  • Large Human Trial

Background and aim

Diagnostic performance of esophagogastroduodenoscopy (EGD) may be compromized due to adherent mucus and foam. In this study, we aimed at assessing the impact of premedication on mucosal visibility during endoscopy.

Methods

This is a double-blinded (patient and investigator), randomized trial conducted at a tertiary care centre. Patients were randomized into four groups: A (water), B (simethicone [S]), C (N-acetyl cysteine [NAC]), D (S + NAC). Premedication solutions were administered 10-30 minutes before endoscopy and mucosal visibility graded from 1 (best) to 4 (worst) (1 best, 4 worst). Total mucosal visibility scores (TMVS) from six sites ranged from 6 (best) to 24 (worst) points. The primary outcome of study was comparison of TMVS between simethicone and combination (S + NAC) premedication groups. Secondary outcomes were adverse events and impact of endoscopy timing on TMVS.

Results

Total 800 patients (39 years, 68.8% males) were randomized into four groups. Median TMVS were significantly lower in groups B (7 [6-8]) and D (8 [6-9]) as compared to A (11 [9-13]) and C (10 [8-12]). Proportion of cases with adequate gastric mucosal visibility (score < 7) was 26% in group A, 71% in group B, 36% in group C and 79% in group D. There was no difference in TMVS in groups A and C (p = 0.137). TMVS were significantly lower in late (> 20-30 minutes) vs. early (10-20 minutes) endoscopy sub-group (8 [7-11] vs, 9 ([7-11], p = 0.001). However, TMVS were similar between group B and group D in early endoscopy group (p = 0.451). There was no significant difference in the lesion detection rate among the different premedication drugs (p > 0.05).

Conclusions

Premedication with simethicone or combination (simethicone and NAC) significantly improves mucosal visibility during EGD. If early endoscopy is indicated, simethicone provides similar mucosal visibility and may be an effective alternative to combined premedication.

Trial registration

NCT05951712.

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