Background: A double-blind placebo-controlled randomized trial was conducted to investigate the safety and the efficacy of orally administered midazolam as preme dication for patients undergoing elective EGD. Methods: A total of 130 patient s were randomized to receive either 7.5 mg of midazolam orally (n = 65) or a pla cebo (n = 65) as premedication. Outcomes measures included the anxiety score (vi sual analog scale) during EGD, overall tolerance, extent of amnesia, overall sat isfaction,patient willingness to repeat the procedure, recovery time, and hemody namic changes after medication. Results: The median(interquar- tile range) anxiety score during the procedure in the midazolam group was sign ificantly lower than that in the control group (2.0 [0-4.9] vs. 3.8 [2.1-7.95] , p < 0.001).A significantly greater number of patients in the midazolam group g raded overall tolerance as “excellent or good“ (70.8%vs. 49.2%, p = 0.012) an d reported a partial to complete amnesia response (52.3%vs. 32.3%, p = 0.02) w hen compared with the control group. Patients in the midazolam group were more w illing to repeat the procedure if necessary (89.2%vs. 69.2%,p = 0.005). The me dian (interquartile range) recovery time was significantly longer in the midazol am group than in the control group (5 [5-15] minutes vs. 5 [5-10] minutes, p = 0.014). There were no statistically significant differences in satisfaction sco re and hemodynamic changes between groups. Conclusions: Premedication by oral ad ministration ofmidazolam is a safe and an effective method of sedation that sign ificantly reduces anxiety and improves overall tolerance for patients undergoing EGD. Background: A double-blind placebo-controlled randomized trial was conducted to investigate the safety and the efficacy of orally administered midazolam as preme dication for patients undergoing elective EGD. Methods: A total of 130 patient s were randomized to receive either 7.5 mg of midazolam orally (n = 65) or a pla cebo (n = 65) as premedication. Outcomes measures included the anxiety score (vi sual analog scale) during EGD, overall tolerance, extent of amnesia, overall sat isfaction, patient willingness to repeat the procedure , recovery time, and hemody namic changes after medication. Results: The median (interquar-tile range) anxiety score during the procedure in the midazolam group was significantly lower than that in the control group (2.0 [0-4.9] vs. 3.8 [2.1-7.95], p <0.001). A significantly greater number of patients in the midazolam group g raded overall tolerance as ”excellent or good" (70.8% vs. 49.2%, p = 0.012) an d reported a partial to complete amnesia response (5 Patients in the midazolam group were more willing to repeat the procedure if necessary (89.2% vs. 69.2%, p = 0.005). The me dian (interquartile range) recovery time was significantly longer in the midazol am group than in the control group (5 [5-15] minutes vs. 5 [5-10] minutes, p = 0.014). Conclusions: Premedication by oral ad ministration of midazolam is a safe and an effective method of sedation that significantly reduces anxiety and improves overall tolerance for patients undergoing EGD.