Background:
Remimazolam tosilate is a new ultra-short-acting
benzodiazepine sedative medicine. In this study, we evaluated the effect of
remimazolam tosilate on the incidence of
hypoxemia during sedation in elderly patients undergoing gastrointestinal endoscopy. Methods: Patients in the
remimazolam group received an initial dose of 0.1 mg/kg and a bolus dose of 2.5 mg of
remimazolam tosilate, whereas patients in the
propofol group received an initial dose of 1.5 mg/kg and a bolus dose of 0.5 mg/kg of
propofol. Patients received ASA standard monitoring (heart-rate, non-invasive blood pressure, and pulse oxygen saturation) during the entire examination process. The primary outcome was the incidence of moderate
hypoxemia (defined as 85%≤ SpO2< 90%, >15s) during the gastrointestinal endoscopy. The secondary outcomes included the incidence of mild
hypoxemia (defined as SpO2 90%-94%) and severe
hypoxemia (defined as SpO2< 85%, >15s), the lowest pulse oxygen saturation, airway maneuvers used to correct
hypoxemia, patient's hemodynamic as well as other adverse events. Results: 107 elderly patients (67.6 ± 5.7 years old) in the
remimazolam group and 109 elderly patients (67.5 ± 4.9 years old) in the
propofol group were analyzed. The incidence of moderate
hypoxemia was 2.8% in the
remimazolam group and 17.4% in the
propofol group (relative risk [RR] = 0.161; 95% confidence interval [CI], 0.049 to 0.528; p < 0.001). The frequency of mild
hypoxemia was less in the
remimazolam group, but not statistically significant (9.3% vs. 14.7%; RR = 0.637; 95% CI, 0.303 to 1.339; p = 0.228). There was no significant difference in the incidence of severe
hypoxemia between the two groups (4.7% vs. 5.5%; RR = 0.849; 95% CI, 0.267 to 2.698; p = 0.781). The median lowest SpO2 during the examination was 98% (IQR, 96.0%-99.0%) in patients in the
remimazolam group, which was significantly higher than in patients in the
propofol group (96%, IQR, 92.0%-99.0%, p < 0.001). Patients in the
remimazolam group received more drug supplementation during endoscopy than patients in the
propofol group (p = 0.014). There was a statistically significant difference in the incidence of
hypotension between the two groups (2.8% vs. 12.8%; RR = 0.218; 95% CI, 0.065 to 0.738; p = 0.006). No significant differences were found in the incidence of adverse events such as
nausea and
vomiting,
dizziness, and prolonged sedation. Conclusion: This study explored the safety of
remimazolam compared with
propofol during gastrointestinal endoscopy in elderly patients. Despite the increased supplemental doses during sedation,
remimazolam improved risk of moderate
hypoxemia (i.e., 85%≤ SpO2 < 90%) and
hypotension in elderly patients.