Evaluation of the Efficacy of Intra-nasal Midazolam for Sedation during Upper Endoscopy: A Randomized Clinical Pilot Study

Abstract

Background :Upper endoscopy, as an important diagnostic and occasional therapeutic tool is invasive. Sedation of patients during the endoscopy procedure with minimal side effects could raise patient tolerability, allowing for ease and increased effectiveness of this procedure.Materials and Methods:In this study, 105 patients who were candidates for the upper endoscopy procedure were randomly divided into two groups: (A) midazolam (n=53) and (B) placebo (n=52). Group A patients received 5 mg of midazolam dissolved in 5 cc distilled water and group B received 5 cc of distilled water, via an intra-nasal drip. After 40 to 45 minutes, the upper endoscopy was performed. During the endoscopy, patients were monitored and the endoscopy time, gag reflex stimulation, heart rate, arterial oxygen saturation (SPO2), amnesia and patient justification were recorded and compared.Results:The average age in group A was 39.3 years; for group B, it was 39.9 years. There were no statistically significant results for average endoscopy time (p=0.23), gag reflex stimulation (p=0.27), heart rate (p=0.09), SPO2 (p=0.49), amnesia (p=0.12), and patient justification (p= 0.1) between both groups.Conclusion:According to the results of this study, it seems that intra-nasal midazolam is not effective for patient sedation. This field needs additional evaluation.