Efficacy and safety of remimazolam-based sedation for intensive care unit patients undergoing fiberoptic bronchoscopy: a single-center prospective randomized controlled study.

OBJECTIVES

The analgesic and sedative strategies during fiberoptic bronchoscopy(FB) in critically ill patients are rarely studied.Remimazolam is a novel sedative whose metabolism is not affected by liver and kidney function.We did a prospective randomized controlled study to compare the efficacy and safety of remimazolam and propofol in sedation therapy for FB patients with liver and kidney dysfunction.

METHODS

The study was conducted in the Third Affiliated Hospital of Sun Yat-sen University (China) from September 2021 to December 2022. 120 adult patients were included, randomly assigned to two groups (the remimazolam or the propofol group) and achieved moderate sedation and successful bronchoscopy.The operation process of FB and changes in liver and kidney function indicators after FB operation were all recorded.

RESULTS

All patients successfully completed the FB with no difference between the two groups in terms of the median time to achieve the target sedation depth (5 min vs. 5 min, P > 0.05).The remimazolam group required fewer sedation rescues (3.33% vs. 16.67%, P = 0.03). The incidence of hypotension was significantly lower in the remimazolam group (3.33% vs. 20%, P = 0.01).The median time to return to the pre-test level of consciousness was similar between the two groups (7 min vs. 7 min, P > 0.05). There was no significant difference in liver and kidney function indexes between the two groups (P > 0.05).

CONCLUSIONS

Remimazolam demonstrated a sedative effect that was not inferior to propofol.

TRIAL REGISTRATION: The Chinese Clinical Trial Registry (chiCTR.gov):No. ChiCTR2100050181, Date of registration: August 15, 2021. The date of enrolment of the first research participant was September 15,2021.