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Published on: September 24, 2020
Efficacy and safety of remimazolam-based sedation for intensive care unit patients undergoing fiberoptic
Yufeng He1, Ziyu Li1, Yunshan Zou1
1Department of Surgical Intensive Care Unit (SICU), the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, 510630, China.
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.
Insights
Remimazolam offers comparable sedation to propofol for fiberoptic bronchoscopy in critically ill patients with liver and kidney dysfunction. This novel sedative demonstrated a similar recovery time and did not impact organ function, with fewer required sedation rescues.
Area of Science:
- Critical Care Medicine
- Anesthesiology
- Pulmonology
Background:
- Sedation strategies for fiberoptic bronchoscopy (FB) in critically ill patients with liver and kidney dysfunction are understudied.
- Remimazolam, a novel sedative, is metabolized independently of liver and kidney function, making it a potential alternative for these patients.
Purpose of the Study:
- To compare the efficacy and safety of remimazolam versus propofol for sedation during FB in critically ill patients with hepatic and renal impairment.
- To evaluate remimazolam's sedative effect and its impact on liver and kidney function in this specific patient population.
Main Methods:
- A prospective randomized controlled study involving 120 adult patients undergoing FB.
- Patients were randomly assigned to receive either remimazolam or propofol for moderate sedation.
- FB procedures and changes in liver and kidney function indicators were monitored.
Main Results:
- Both remimazolam and propofol achieved target sedation depth equally quickly (median 5 min).
- The remimazolam group required significantly fewer sedation rescues (3.33% vs. 16.67%) and had a lower incidence of hypotension (3.33% vs. 20%).
- Recovery to pre-test consciousness levels was similar (median 7 min), with no significant differences in liver and kidney function post-procedure.
Conclusions:
- Remimazolam provides a sedative effect non-inferior to propofol for FB in patients with liver and kidney dysfunction.
- Remimazolam is a safe and effective alternative, showing improved safety profiles regarding sedation rescue and hypotension.
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