Efficacy and Safety of Using Premedication with Simethicone/Pronase during Upper Gastrointestinal Endoscopy Examination with Sedation: A Single Center, Prospective, Single Blinded, Randomized Controlled Trial

Objectives To investigate the efficacy and safety of premedication with simethicone/pronase during esophagogastroduodenoscopy (EGD) with sedation. Methods 610 patients were randomly allocated to two groups based on the type of premedication given. The premedication used in the control group was 10ml of lidocaine hydrochloride mucilage (LHM, N=314) and the premedication used in the intervention group was 80mL of simethicone/pronase solution plus 10ml of lidocaine hydrochloride mucilage (SP/LHM, N=296). The EGD was performed under sedation. The visibility scores, number of mucosal areas that need to be cleansed, water consumption for cleansing, time taken for the examination, diminutive lesion, pathological diagnosis, patients’ gag reflex and the oxygenation (pulse oximetry) were recorded. Results The SP/LHM has significantly lower total visibility score than the LHM (7.978±1.526 vs 6.348±1.097, p<0.01). During the procedure, the number of intragastric area that needed to be cleansed and water consumption were significantly lesser in the SP/LHM than in the LHM (p<0.01). In the SP/LHM (p=0.01), the endoscopy procedure duration was significantly longer. Although there was no significant difference of the rate of detection of diminutive lesion between LHM and SP/LHM, the endoscopist performed more biopsies in the SP/LHM. This in turn leads to higher rate of diagnosis of atrophic gastritis (p =0.014) and intestinal metaplasia (p =0.024). There was no significant difference in gag reflex (p=0.604) and oxygenation during the endoscopy procedure for both group of patients. Conclusion The routine use of premedication with Simethicone/Pronase should be recommended during EGD with sedation. This article is protected by copyright. All rights reserved.