Effects of premedication with Pronase for endoscopic ultrasound of the stomach: A randomized controlled trial.

Abstract

AIMTo analyze the effects of premedication with Pronase for endoscopic ultrasound (EUS) examination of the stomach.METHODSThis was a prospective, randomized and controlled clinical study. All patients were randomly assigned to either the Pronase group or placebo group. The pretreatment solution was a mixed solution of 20000 U of Pronase and 60 mL sodium bicarbonate solution in the Pronase group, while an equal amount of sodium bicarbonate solution was administered to the placebo group. All operators, image evaluators and experimental recorders in EUS did not participate in the preparation and allocation of pretreatment solution. Two blinded investigators assessed the obscurity scores for the EUS images according to the size of artifacts (including ultrasound images of the gastric cavity and the gastric wall). Differences in imaging quality, the duration of examination and the usage of physiological saline during the examination process between the Pronase group and the control group were compared.RESULTSNo differences existed in patient demographics between the two groups. For the gastric cavity, the Pronase group had significantly lower mean obscurity scores than the placebo group (1.0476 ± 0.77 vs 1.6129 ± 0.96, respectively, P = 0.000). The mean obscurity scores for the gastric mucosal surface were significantly lower in the Pronase group than the placebo group (1.2063 ± 0.90 vs 1.7581 ± 0.84, respectively, P = 0.001). The average EUS procedure duration for the Pronase group was 11.60 ± 3.32 min, which was significantly shorter than that of the placebo group (13.13 ± 3.81 min, P = 0.007). Less saline was used in the Pronase group than the placebo group, and the difference was significant (417.94 ± 121.38 mL vs 467.42 ± 104.52 mL, respectively, P = 0.016).CONCLUSIONThe group that had Pronase premedication prior to the EUS examination had clearer images than the placebo group. With Pronase premedication, the examination time was shorter, and the amount of saline used during the EUS examination was less.