Effect of remimazolam besylate versus midazolam on time to extubation in critically ill, mechanically ventilated patients: a randomized controlled trial
BackgroundPrevious studies have indicated that the administration of short-acting sedatives prior to weaning from mechanical ventilation is linked to a more rapid recovery and extubation process, in addition to lowering intensive care unit (ICU) treatment expenses. The present study aimed to evaluat...
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Frontiers Media S.A.
2025-08-01
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| author | Renhuai Liu Binxiao Su Guifen Gan Guangming Wang Chengli Wang Ning Xu Guangcai Feng Hao Guo Qingxia Yuan Aiguang Li Wenping Zheng Jiang Li Yu Chen Xijing Zhang |
| author_facet | Renhuai Liu Binxiao Su Guifen Gan Guangming Wang Chengli Wang Ning Xu Guangcai Feng Hao Guo Qingxia Yuan Aiguang Li Wenping Zheng Jiang Li Yu Chen Xijing Zhang |
| author_sort | Renhuai Liu |
| collection | DOAJ |
| description | BackgroundPrevious studies have indicated that the administration of short-acting sedatives prior to weaning from mechanical ventilation is linked to a more rapid recovery and extubation process, in addition to lowering intensive care unit (ICU) treatment expenses. The present study aimed to evaluate the efficacy and safety of the sequential administration of remimazolam besylate compared with midazolam before weaning from mechanical ventilation.MethodsThis multicenter, randomized controlled trial was conducted across medical and surgical ICUs within a tertiary, academic medical center. The study population consisted of critically ill, mechanically ventilated adult patients. Candidates anticipated to be ready for ventilator weaning within 12 h underwent a Spontaneous Breathing Trial (SBT) safety screen. Only those who successfully passed this assessment were considered for inclusion in the final phase of the study and subsequent randomization. The patients were randomized into two groups: group M, in which the sedative regimen was transitioned to midazolam, and group R, which involved a switch to remimazolam. Sedative dosages were titrated to achieve a target Richmond Agitation-Sedation Scale (RASS) score between −3 and 0. The primary endpoint of this study was the time to extubation.ResultsA total of 435 patients underwent screening, of whom 306 patients being randomized, and 272 patients ultimately included in the analysis, comprising 132 patients in group M and 140 patients in group R. The patients in group R maintained lighter levels of sedation compared to those in group M. The patients in group R showed significantly earlier recovery (p < 0.05) and extubation (p < 0.05) at the same RASS score prior to the cessation of sedatives. Higher prevalence of agitation was observed in group M as opposed to group R (20.45% versus 8.57%, p = 0.005). However, no significant difference in the incidence of delirium was noted between the groups.ConclusionIn critically ill, mechanically ventilated patients, the use of remimazolam besylate was associated with a shorter time to recovery and extubation prior to ventilator weaning, along with a lower incidence of agitation.Clinical trial registrationIdentifier ChiCTR 2200065048, https://www.chictr.org.cn. |
| format | Article |
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| institution | Kabale University |
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| language | English |
| publishDate | 2025-08-01 |
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| spelling | doaj-art-3d937845f01c4eb0867ef51f58bd146c2025-08-26T05:28:09ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-08-011210.3389/fmed.2025.15534951553495Effect of remimazolam besylate versus midazolam on time to extubation in critically ill, mechanically ventilated patients: a randomized controlled trialRenhuai Liu0Binxiao Su1Guifen Gan2Guangming Wang3Chengli Wang4Ning Xu5Guangcai Feng6Hao Guo7Qingxia Yuan8Aiguang Li9Wenping Zheng10Jiang Li11Yu Chen12Xijing Zhang13Department of Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Critical Care Medicine, Affiliated Hospital of Qinghai University, Xining, ChinaDepartment of Critical Care Medicine, Norinco General Hospital, Xi’an, Shaanxi, ChinaDepartment of Critical Care Medicine, 3201 Hospital, Hanzhong, Shaanxi, ChinaDepartment of Critical Care Medicine, The Second Affiliated Hospital of Yan’an University, The First Hospital of Yulin, Yulin, Shaanxi, ChinaDepartment of Intensive Care Medicine, Ankang Traditional Chinese Medicine Hospital, Ankang, Shaanxi, ChinaDepartment of Critical Care Medicine, Xianyang First People's Hospital, Xianyang, Shaanxi, ChinaDepartment of Intensive Care Unit, Xi'an International Medical Center Hospital, Xi’an, Shaanxi, ChinaDepartment of Critical Care Medicine, Xi'an Aerospace General Hospital, Xi’an, Shaanxi, China0Department of Neurosurgery, Hancheng People's Hospital, Hancheng, Shaanxi, China1Department of Critical Care Medicine, Ankang Central Hospital, Ankang, Shaanxi, ChinaDepartment of Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaDepartment of Critical Care Medicine, Xijing Hospital, Fourth Military Medical University, Xi’an, Shaanxi, ChinaBackgroundPrevious studies have indicated that the administration of short-acting sedatives prior to weaning from mechanical ventilation is linked to a more rapid recovery and extubation process, in addition to lowering intensive care unit (ICU) treatment expenses. The present study aimed to evaluate the efficacy and safety of the sequential administration of remimazolam besylate compared with midazolam before weaning from mechanical ventilation.MethodsThis multicenter, randomized controlled trial was conducted across medical and surgical ICUs within a tertiary, academic medical center. The study population consisted of critically ill, mechanically ventilated adult patients. Candidates anticipated to be ready for ventilator weaning within 12 h underwent a Spontaneous Breathing Trial (SBT) safety screen. Only those who successfully passed this assessment were considered for inclusion in the final phase of the study and subsequent randomization. The patients were randomized into two groups: group M, in which the sedative regimen was transitioned to midazolam, and group R, which involved a switch to remimazolam. Sedative dosages were titrated to achieve a target Richmond Agitation-Sedation Scale (RASS) score between −3 and 0. The primary endpoint of this study was the time to extubation.ResultsA total of 435 patients underwent screening, of whom 306 patients being randomized, and 272 patients ultimately included in the analysis, comprising 132 patients in group M and 140 patients in group R. The patients in group R maintained lighter levels of sedation compared to those in group M. The patients in group R showed significantly earlier recovery (p < 0.05) and extubation (p < 0.05) at the same RASS score prior to the cessation of sedatives. Higher prevalence of agitation was observed in group M as opposed to group R (20.45% versus 8.57%, p = 0.005). However, no significant difference in the incidence of delirium was noted between the groups.ConclusionIn critically ill, mechanically ventilated patients, the use of remimazolam besylate was associated with a shorter time to recovery and extubation prior to ventilator weaning, along with a lower incidence of agitation.Clinical trial registrationIdentifier ChiCTR 2200065048, https://www.chictr.org.cn.https://www.frontiersin.org/articles/10.3389/fmed.2025.1553495/fullremimazolam besylatemidazolamsequential sedationintensive caremechanical ventilation |
| spellingShingle | Renhuai Liu Binxiao Su Guifen Gan Guangming Wang Chengli Wang Ning Xu Guangcai Feng Hao Guo Qingxia Yuan Aiguang Li Wenping Zheng Jiang Li Yu Chen Xijing Zhang Effect of remimazolam besylate versus midazolam on time to extubation in critically ill, mechanically ventilated patients: a randomized controlled trial Frontiers in Medicine remimazolam besylate midazolam sequential sedation intensive care mechanical ventilation |
| title | Effect of remimazolam besylate versus midazolam on time to extubation in critically ill, mechanically ventilated patients: a randomized controlled trial |
| title_full | Effect of remimazolam besylate versus midazolam on time to extubation in critically ill, mechanically ventilated patients: a randomized controlled trial |
| title_fullStr | Effect of remimazolam besylate versus midazolam on time to extubation in critically ill, mechanically ventilated patients: a randomized controlled trial |
| title_full_unstemmed | Effect of remimazolam besylate versus midazolam on time to extubation in critically ill, mechanically ventilated patients: a randomized controlled trial |
| title_short | Effect of remimazolam besylate versus midazolam on time to extubation in critically ill, mechanically ventilated patients: a randomized controlled trial |
| title_sort | effect of remimazolam besylate versus midazolam on time to extubation in critically ill mechanically ventilated patients a randomized controlled trial |
| topic | remimazolam besylate midazolam sequential sedation intensive care mechanical ventilation |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2025.1553495/full |
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