Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study

Abstract 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 receivin...

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Main Authors: Youli Tian, Jintong Li, Minggen Jin, YiHua Piao, Jisheng Sheng, Zhixiong Mei, Qingsong Cui, Lilin Li
Format: Article
Language:English
Published: SpringerOpen 2025-01-01
Series:Annals of Intensive Care
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Online Access:https://doi.org/10.1186/s13613-025-01431-5
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author Youli Tian
Jintong Li
Minggen Jin
YiHua Piao
Jisheng Sheng
Zhixiong Mei
Qingsong Cui
Lilin Li
author_facet Youli Tian
Jintong Li
Minggen Jin
YiHua Piao
Jisheng Sheng
Zhixiong Mei
Qingsong Cui
Lilin Li
author_sort Youli Tian
collection DOAJ
description Abstract 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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spelling doaj-art-19a8a1e8177147929c2e6f01d714dc742025-01-19T12:38:35ZengSpringerOpenAnnals of Intensive Care2110-58202025-01-0115111110.1186/s13613-025-01431-5Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective studyYouli Tian0Jintong Li1Minggen Jin2YiHua Piao3Jisheng Sheng4Zhixiong Mei5Qingsong Cui6Lilin Li7Department of Intensive Care Unit, Yanbian University HospitalDepartment of Intensive Care Unit, Yanbian University HospitalDepartment of Intensive Care Unit, Yanbian University HospitalDepartment of Intensive Care Unit, Yanbian University HospitalDepartment of Intensive Care Unit, Yanbian University HospitalDepartment of Intensive Care Unit, Yanbian University HospitalDepartment of Intensive Care Unit, Yanbian University HospitalDepartment of Intensive Care Unit, Yanbian University HospitalAbstract 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.https://doi.org/10.1186/s13613-025-01431-5RemimazolamPropofolAnalgesia and sedationIntensive care unit
spellingShingle Youli Tian
Jintong Li
Minggen Jin
YiHua Piao
Jisheng Sheng
Zhixiong Mei
Qingsong Cui
Lilin Li
Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study
Annals of Intensive Care
Remimazolam
Propofol
Analgesia and sedation
Intensive care unit
title Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study
title_full Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study
title_fullStr Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study
title_full_unstemmed Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study
title_short Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study
title_sort procedural sedative effect of remimazolam in icu patients on invasive mechanical ventilation a randomised prospective study
topic Remimazolam
Propofol
Analgesia and sedation
Intensive care unit
url https://doi.org/10.1186/s13613-025-01431-5
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