Conscious sedation for EUS of the esophagus and stomach: a double-blind, randomized, controlled trial comparing midazolam with placebo

Background: Patients undergoing EUS usually receive intravenously administered sedative medication. A double-blind, prospective, randomized trial was conducted to compare midazolam with a placebo for EUS of the esophagus and stomach and to assess patient tolerance and endoscopic feasibility. Methods: A total of 111 patients were randomized to receive midazolam or a placebo. Patients used a visual analogue scale to score pre-EUS anxiety and tolerance for the procedure. Endoscopists used a visual analogue scale to score ease of echoendoscope introduction and overall patient cooperation. Subsequent to EUS, patients were asked if they were willing to undergo the procedure under the same conditions. Results: The patients' visual analogue scale scores indicated that tolerance for the introduction of the echoendoscope and the procedure overall were both significantly better in the midazolam group. Overall patient tolerance was predicted by sedation (p < 0.001) and pre-EUS anxiety (p = 0.024). Endoscopists' visual analogue scale scores showed that ease of echoendoscope introduction was significantly better in the midazolam group. There was no significant difference in overall patient cooperation during the procedure. There were no significant differences in introduction time, total procedure time, or patients' willingness to undergo the procedure under the same conditions. Conclusions: EUS of the esophagus and stomach without intravenous sedation is feasible for endoscopists and patients. Patients prefer intravenous administration of midazolam. Assessment of anxiety before EUS may indicate whether administration of midazolam can improve tolerance for the individual patient.