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

Abstract

Background: Postoperative delirium is common in older adult patients and associated with a poor prognosis. The use of benzodiazepine was identified as an independent risk factor for delirium, but there is no randomized controlled trial regarding the relationship between remimazolam, a new ultra-short acting benzodiazepine, and postoperative delirium. We designed a randomized controlled trial to evaluate if remimazolam increases the incidence of postoperative delirium compared with propofol in older adult patients undergoing orthopedic surgery with general anesthesia. Patients and Methods: We enrolled 320 patients aged more than 60 with American Society of Anesthesiologists physical status I-III who underwent orthopedic surgery. Patients were randomized to two groups to receive intraoperative remimazolam or propofol, respectively. Our primary outcome was the incidence of delirium within 3 days after surgery. Secondary outcome was emergence quality including the incidence of emergence agitation, extubation time, and length of post-anesthesia care unit (PACU) stay. Adverse events were also recorded. Results:The incidence of postoperative delirium was 15.6% in the remimazolam group and 12.4% in the propofol group (Risk ratio, 1.26; 95% CI, 0.72 to 2.21; Risk difference, 3.2%; 95% CI, −4.7% to 11.2%; P = 0.42). No significant differences were observed for time of delirium onset, duration of delirium, and delirium subtype between the two groups. Patients in remimazolam group had a lower incidence of hypotension after induction and consumed less vasoactive drugs intraoperatively, but had a longer postoperative extubation time and PACU stay. Conclusion: General anesthesia with remimazolam was not associated with an increased incidence of postoperative delirium compared with propofol in older adult patients undergoing orthopedic surgery.

Remimazolam for the prevention of emergence agitation in adult following nasal surgery under general anesthesia: A randomized controlled study

“…15 In addition, compared with dexmedetomidine, remimazolam is also effective in reducing the incidence of EA in elderly patients after orthopedic surgery. 16,17 The results also showed that there was no signi cant difference in extubation time and length of PACU stay between the two groups. This may be related to the pharmacological properties of remimazolam, which has been con rmed by multiple studies to have no effect on postoperative recovery time.…”

Remimazolam for Procedural Sedation in Older Patients: A Systematic Review and Meta-Analysis with Trial Sequential Analysis

“…Further evidence related to delirium in older patients and procedural sedation, such as general anesthesia in clinical practice, is essential for clarification of the pros and cons of using remimazolam for procedural sedation in older patients. Yang et al reported that general anesthesia with remimazine in older patients undergoing orthopedic surgery did not result in an increase in postoperative delirium compared with propofol [ 33 ]. Recently, research on remimazolam has been increasing.…”

Effect of remimazolam on electroencephalogram burst suppression in elderly patients undergoing cardiac surgery: Protocol for a randomized controlled noninferiority trial

“…Duan et al enrolled 60 elderly patients who had hip replacement to show that remimazolam anesthesia, when compared with propofol anesthesia, could reduce the incidence of emergence agitation [ 38 ]. Another recent study found that remimazolam anesthesia did not increase POD among elderly patients undergoing orthopedic surgical procedures [ 39 ]. However, the role of remimazolam in cardiac surgery and its impact on POD are largely unknown.…”