Effect of remimazolam besylate compared with propofol on the incidence of delirium after cardiac surgery: study protocol for a randomized trial

Abstract

Background Delirium is an acute cognitive disorder that presents with fluctuation in cognition, apathy, and non-organized thinking, resulting in increased morbidity, mortality, intensive care unit (ICU) stay, and total healthcare costs. In patients undergoing cardiac surgery, delirium also increases the risk of postoperative complications, such as respiratory insufficiency, sternum instability, and need for re-operation of the sternum. This study aims to understand the incidence of delirium in patients after cardiac surgery in patients sedated with remimazolam besylate versus propofol. Methods In this prospective, double-blind, randomized controlled clinical trial, we aim to recruit 200 patients undergoing cardiac surgery between January 1, 2021, and December 31, 2021, who will be randomized to receive either remimazolam besylate or propofol infusions postoperatively, until they are extubated. The primary outcome is the incidence of delirium within 5 days after surgery. Secondary outcomes include the time of delirium onset, duration of delirium, ICU length of stay, hospital length of stay, and mechanical ventilation time. Discussion The key objective of this study is to assess whether remimazolam besylate reduces the incidence of delirium in patients after cardiac surgery compared to propofol sedation. In this preliminary randomized controlled clinical trial, we will test the hypothesis that the use of remimazolam besylate lowers the incidence of delirium when compared to propofol in patients undergoing cardiac surgery. Trial registration chictr.org.cn ChiCTR2000038976. Registered on October 11, 2020

Effect of Remimazolam on Postoperative Delirium in Older Adult Patients Undergoing Orthopedic Surgery: A Prospective Randomized Controlled Clinical Trial

“…In addition, a published protocol of a RCT aimed to investigate the effects of postoperative sedation with remimazolam versus propofol on POD after cardiac surgery, and we look forward to their results in the near future for a better understanding of the effects of remimazolam on delirium when used in different populations at different time. 36 The total incidence of POD in our study was 14%, which was lower than in previous studies. 23,24 Our lower incidence presumably reflects relatively low baseline risk.…”

Quality of Recovery After General Anesthesia with Remimazolam in Patients’ Undergoing Urologic Surgery: A Randomized Controlled Trial Comparing Remimazolam with Propofol

“…Recently, a clinical trial to evaluate the effect of remimazolam compared with propofol on the incidence of delirium after cardiac surgery was registered. 35 Its results may answer this question more precisely.…”

Remimazolam Supplemented to General Anesthesia Alleviates Stress and Cognitive Impairment in Elder Patients After Hip Surgery

“…The inadequate analgesic effect has been considered one of the contributing factors to postoperative stress and cognitive impairment because of surgery. 16 The analgesic and sedation effects of remimazolam, as previously reported, 17,18 presumably play an important role in pain-relieving, therefore decreasing stress. Surgery is known to upregulate pro-inflammatory cytokines, which is accountable for a variety of negative physical, behavioral, and psychological changes.…”