Sedation Efficacy of Remimazolam Besylate in Elderly Patients Undergoing Non-general Anesthesia and Effects on Perioperative Cognitive Function: A Clinical Trial Protocol

Abstract

Background: During procedures that are not performed under general anesthesia, elderly patients often have adverse emotions such as nervousness and anxiety due to their consciousness. Sedation is frequently used to relieve these symptoms. However, the adverse effects from currently prescribed sedative drugs such as midazolam, dexmedetomidine, and propofol are common and unavoidable. There has been limited research on the use of remimazolam besylate, a new sedative drug, to determine the effectiveness of the medication in reducing perioperative cognitive dysfunction in elderly patients undergoing non-general anesthesia procedures and to assess the efficacy of the medication in reducing sedation. Methods: This prospective, multicenter, randomized, single-blind, placebo-controlled trial was conducted from July 2021 to February 2022. The study included 330 elderly patients aged > 65 years who underwent non-general anesthesia procedures. Patients were randomly assigned (2:1) to two groups: the remimazolam besylate group and control group. Outcomes:The primary outcomes included sedation levels achieved at target doses and changes in perioperative cognitive function. Additionally, time to awakening, the incidence of postoperative delirium, change in anxiety level, change in sleep rhythm, and the incidence of adverse events during sedation were measured as secondary outcomes.