Comparison of Remimazolam and Propofol for Drug-Induced Sleep Endoscopy: A Randomized Clinical Trial.

Abstract

To compare the efficacy and safety of remimazolam with those of propofol for drug-induced sleep endoscopy (DISE) in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS). A prospective, single-center, randomized clinical trial. Xiangya Hospital of Central South University. Patients with OSAHS receiving DISE were randomly assigned to either the remimazolam or propofol group. The primary outcome was the incidence of hypoxemia (pulse oxygen saturation [SpO2 ] < 90%) during DISE. The secondary outcomes were the incidence of severe hypoxemia (SpO2  < 80%), the minimal value of SpO2 , sedation success rate (completion of DISE according to the medication regimen), and incidence of events of interest (including injection pain, bradycardia, and decreased respiratory rate). Sixty-four patients were included in this study. The incidence of hypoxemia was significantly lower in the remimazolam than in the propofol group (25.00% vs62.50%, respectively; relative risk, 0.40; 95% confidence interval [CI], 0.20-0.74; p < .01). There was no significant difference in the sedation success rate between the remimazolam and propofol groups (96.88% vs81.25%, respectively; relative risk, 1.19; 95% CI, 1.01-1.50; p = .10). The incidence of at least 1 event of interest was lower in the remimazolam than in the propofol group (43.75% vs96.88%, respectively; relative risk, 0.45; 95% CI, 0.29-0.63; p < .01). Remimazolam can present satisfactory sedative efficacy in DISE, with a lower incidence of hypoxemia and a higher safety profile than propofol.