PREMEDICATION WITH DIMETHICONE,N-ACETYLCYSTEINE AND PANCREATIN TO IMPROVE VISIBILITY DURING GASTROSCOPY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Aims Evaluate the efficacy and safety of premedication with Dimethicone, N-Acetylcysteine and Pancreatin during upper digestive endoscopy.

Tab. 1 Mucosal visibility scores and secondary outcomes

	Group A n=54 m(SD)	Group B n=55 m(SD)	Group C n=54 m(SD)	p*
Mucosal visibility score Esophagus Stomach Duodenum	2.48 (±0.57) 1.70 (±0.46) 1.85 (±0.65)	2.91 (±0.29) 2.63 (±0.48) 2.89 (±0.31)	2.96 (±0.19) 2.68 (±0.47) 2.92 (±0.26)	0.0001 0.0001 0.0001
Secondary Outcomes Intragastric volume Flush volume required Procedure duration	2.27 (0.53) 14.54 (±9.12) 9.17 (±1.14)	2.14 (±0.55) 3 (±4.03) 7.05 (±1.21)	2.07 (±0.51) 2.59 (±3.60) 6.89 (±0.90)	0.13 0.0001 0.0001

Methods Randomized, double-blind, controlled trial at a National referral center in Mexico. From May to September 2019, 163 patients who underwent routine gastroscopy were recruited. They were randomized 1:1:1 to receive premedication with 100ml of water (Group A); 100ml of water, 100mg of Dimethicone and 600mg of N-Acetylcisteine (Group B); or, 100ml of water, 100mg of Dimethicone, 600mg of N-Acetylcisteine and 300mg of Pancreatin (Group C). Endoscopists and patients were blinded to group allocation. Mucosal visibility was evaluated by 3 experienced endoscopists in the lower esophagus, the stomach (fundus, body, antrum), and in the duodenum. A 3-point previously validated scale was used (1=worst, 3=best). The primary outcome was mucosal visibility. Secondary outcomes were intragastric volume, volume of fluid required to achieve adequate visibility, procedure duration, tolerance, and adverse events. Analysis was done with Kruskal-Wallis test and U Mann-Whitney (Stata v13, p< 0.05).

Results Mean mucosal visibility score, mean flush volume required to achieve adequate mucosa views and procedure duration for Group B and C was better than for Group A ([Table 1]) in lower esophagus, stomach, and duodenum (p 0.0001). No difference was found in intragastric volume between any of the 3 groups (p 0.13). No adverse events were reported, and the three groups experienced good tolerance for the premedication.

Conclusions Premedication with Dimethicone and N-acetylcisteine significantly improves mucosal visibility during gastroscopy. Furthermore, it reduces mean flush volume required to achieve adequate mucosal visibility and procedure duration when compared to placebo.