Effect of the midazolam added with propofol-based sedation in esophagogastroduodenoscopy: A randomized trial

Background and Aim: Although propofol has been widely used for sedation during esophagogastroduodenoscopy (EGD), adverse events including hypoxia and hypotension may be a concern in the propofol-based sedation. We aimed to analyze whether administration of midazolam would improve safety and efficacy of propofol-based sedation in EGD. Methods: One hundred twenty patients who were scheduled to undergo diagnostic EGD were randomly assigned to either midazolam plus propofol (MP) or propofol alone groups. In the MP group, 2 mg of midazolam and 10 mg of propofol were given initially. In the propofol alone group, 40–60 mg of propofol was given initially. In both groups, 20 mg of propofol was given repeatedly to maintain moderate sedation as needed. Vital signs including oxygen saturation were monitored every 2 min. After the patients fully recovered, satisfaction score was investigated from endoscopists, nurses, and patients, respectively. Results: The baseline characteristics did not differ between the MP and propofol alone groups. The mean required doses of propofol was (mean ± standard deviation) 0.3 ± 0.3 and 0.8 ± 0.2 mg/kg in the MP and propofol alone groups, respectively (P < 0.001). In addition, sedation-related adverse events and recovery time did not differ between the two groups. The proportion of satisfactory did not differ between the two groups (MP vs propofol alone; proportion; patient, 95.0% vs 93.3%, P > 0.999; endoscopist, 73.3% vs 80.0%, P = 0.064; nurse, 73.3% vs 76.7%, P = 0.551). Conclusion: Adding midazolam to propofol did not reduced the safety and efficacy, and sedation using propofol alone could be suitable for sedation during diagnostic EGD.