Annals of
Intensive Care volume 15,
Article number: 8 (2025)
Published: 14 January 2025
Background
Invasive procedures
and environmental factors in the intensive care unit (ICU) may cause anxiety
and discomfort in patients, who often require sedation therapy. The aim of this
study was to assess the safety of remimazolam tosilate for procedural sedation
in ICU patients receiving mechanical ventilation following endotracheal
intubation. Eighty patients from a single centre were randomly assigned to
either the propofol group or the remimazolam group. Blood tests were conducted
to evaluate changes in lactate, blood lipids, liver and kidney function, and
inflammatory markers, and patients’ vital signs were observed over several
periods. This study compared the incidence of delirium, the impact on liver and
kidney function, circulatory effects, and changes in blood lipids between the
two groups. These findings have optimised the selection of medications,
providing ICU patients with more options for sedation therapy.
Methods
In this
single-centre randomised controlled trial, intubated patients were randomly
assigned to the remimazolam group or the propofol group. Under the same
analgesic regimen, the two groups received remimazolam and propofol for
procedural sedation.
Results
Our primary outcome
was the mean arterial pressure (MAP), which significantly differed on Days 4
and 7 (P = 0.021, control group vs. experimental group = 85.23 ± 11.24
vs. 94.36 ± 13.18, P = 0.023,
83.55 ± 8.94 vs. 92.66 ± 7.02). With respect to
liver and kidney function, the ∆AST value in the
remimazolam group was significantly lower than that in the control group on Day
7 (P = 0.023). There were significant differences
in triglyceride (TG) levels on Days 4 and 7 (P = 0.020) and in the ∆LDL on Day 7 (P = 0.027). Furthermore, the rates of
dyslipidaemia and delirium in the remimazolam group were lower than those in
the propofol group (85.0%, n = 40 vs. 90.0%, n = 40;
27.5%, n = 40 vs. 55%, n = 40).
Conclusion
Remimazolam is a
novel benzodiazepine that has demonstrated promising applications in general
anaesthesia and procedural sedation; however, its use in ICU sedation is still
in the early stages of research. Current evidence suggests that remimazolam is
a safe sedative that is particularly well suited for patients with haemodynamic
instability. Large sample-size randomised clinical trials are warranted.
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