AUTHOR=Liu Fang , Cheng Xiaoyan , Wang Yingjie , Li Kai , Peng Tianliang , Fang Ningning , Pasunooti Kalyan K. , Jun Seungho , Yang Xiaomei , Wu Jianbo 

TITLE=Effect of remimazolam tosilate on the incidence of hypoxemia in elderly patients undergoing gastrointestinal endoscopy: A bi-center, prospective, randomized controlled study

JOURNAL=Frontiers in Pharmacology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1131391

DOI=10.3389/fphar.2023.1131391

ISSN=1663-9812

ABSTRACT=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 0.1mg/kg and a bolus dose of 2.5mg of remimazolam tosilate, whereas patients in the propofol group received an initial dose of 1.5mg/kg and a bolus dose of 0.5mg/kg of propofol. Patients received ASA standard monitoring (heart-rate, noninvasive 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% to 99.0%) in patients in the remimazolam group, which was significantly higher than in patients in the propofol group (96%, IQR, 92.0% to 99.0%, P <0.001). 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).Conclusion:Despite the increased supplemental doses during sedation, remimazolam improved risk of moderate hypoxemia (i.e., 85%≤ SpO2< 90%) and hypotension in elderly patients.