Background: Elective patients usually undergo upper gastrointestinal endoscopy (EGD) without any
sedation. Sedation before EGD may reduce patient’s anxiety and the procedure may be performed more effectively.
The purpose of this study was to evaluate the effectiveness and adverse events of oral midazolam compared with
placebo in patients undergoing EGD.
Methods: A double-blinded randomized controlled trial was carried out in elective EGD patients. Patients
were allocated, using block-of-four randomization, to receive either 5 mg of oral midazolam or placebo 30
minutes before the procedure. Measurements were made and compared, including decreasing anxiety score (visual
analog scale) between baseline and during EGD, overall tolerance, extent of amnesia, overall satisfaction, willingness
to repeat the procedure, and hemodynamic changes after medication.
Results: Two-hundred-and-sixty patients were randomized to receive midazolam or placebo, 130 patients
in each group. Fifty-fifth percent of study patients were male, and the mean age of all patients was 53.74 ±
11.74. The median (interquartile range) of decreasing anxiety score between baseline and during EGD was significant
greater in the midazolam group than in the placebo group (-5 [-6, -4] vs -1 [-1, 0], p<0.001). Overall tolerance,
which was classified as “Good” or “Excellent”, was significantly greater in the midazolam group than in the placebo
group (92.3% vs 26.9%, p<0.001). Patients in the midazolam group had a higher partial to complete amnesia
score than in the placebo group (18.5% vs 90.8%, p<0.001). Overall satisfaction score for both patients and doctors
were better in the group receiving midazolam (7.72 ± 1.01 vs 5.22 ± 1.59, 7.53 ± 0.99 vs 5.23 ± 1.29; p<0.001).
Most patients in both groups were willing to repeat EGD again if necessary. No patients were observed to have
aspiration, hypotension or desaturation by pulse oximetry.
Conclusion: Oral midazolam can be used effectively as a sedative drug in patients undergoing elective
EGD. It reduces patient’s anxiety significantly without causing any significant adverse events.