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

Jan 30, 2023Drug design, development and therapy

Remimazolam and the risk of confusion after orthopedic surgery in older adults

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Abstract

The incidence of was 15.6% in the remimazolam group compared to 12.4% in the propofol group.

Remimazolam did not significantly increase the incidence of postoperative delirium compared to propofol, with a risk ratio of 1.26.
No significant differences were noted in the timing, duration, or subtype of delirium between the two groups.
Patients receiving remimazolam experienced less hypotension and required fewer vasoactive drugs during surgery.
The remimazolam group had a longer postoperative extubation time and extended stay in the post-anesthesia care unit.

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BACKGROUND: 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.

Key numbers

15.6%

Incidence

Incidence in remimazolam group

12.4%

Incidence

Incidence in propofol group

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

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