Efficacy and safety of remimazolam for sedation during endoscopic procedures in Japanese: A prospective phase III clinical trial.

Abstract

Objectives: Remimazolam is a general anesthetic with a short elimination half-life and its pharmacokinetics are less affected by liver and kidney function. It may be useful for sedation during endoscopic procedures in patients. This single-arm clinical trial aimed to evaluate the efficacy and safety of remimazolam for sedation in patients undergoing endoscopic procedures.

Methods: Patients undergoing endoscopic procedures were included in this study. Remimazolam was administered intravenously with opioid analgesics, and the endoscopic procedure was started after an efficient level of sedation (Modified Observer's Assessment of Alertness/Sedation score ≤3) was achieved. The primary end-point for efficacy was the sedation success rate during the endoscopic procedures. Data on adverse events were collected for safety evaluation.

Results: Sixty-two patients were included in the analysis. The sedation success rate of 93.5% (84.3-98.2%) exceeded the threshold success rate of 80% (P = 0.004). In all, 98.4% of patients were appropriately sedated before endoscope insertion. The median time from the first dose of remimazolam to achieving sedation was 4.0 min, while the median time from the end of the endoscopic procedure to being deemed ready to leave the room was 2.0 min. Adverse events were observed in 22 cases (35.5%). The severity of adverse events was moderate in five cases (8.1%), mild in 17 cases (27.4%), and there was no severe case.

Conclusion: Sedation with remimazolam plus opioid analgesics was effective and well tolerated, regardless of endoscopic procedure site. These findings suggest that remimazolam is a useful sedative during endoscopic procedures.