PMID- 34386505
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210814
IS  - 2296-858X (Print)
IS  - 2296-858X (Electronic)
IS  - 2296-858X (Linking)
VI  - 8
DP  - 2021
TI  - Efficacy and Safety of Remimazolam for Procedural Sedation: A Meta-Analysis of 
      Randomized Controlled Trials With Trial Sequential Analysis.
PG  - 641866
LID - 10.3389/fmed.2021.641866 [doi]
LID - 641866
AB  - Background: Remimazolam is a new ultrashort-acting benzodiazepine. Remimazolam 
      has been approved for procedural sedation by the US Food and Drug Administration 
      in 2020. However, prior trials and the participants they enrolled were limited. 
      Aim: In this meta-analysis, we investigated the effectiveness and adverse events 
      (AEs) of remimazolam during procedural sedation. Materials and Methods: The study 
      protocol was registered (doi: 10.37766/inplasy2020.8.0043), and six databases 
      were searched. We performed meta-analysis, trial sequential analysis (TSA), and 
      Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) 
      methodology for judging the certainty of evidence (CoE). Results: A total of five 
      randomized controlled trials with 1,248 participants were included. Compared with 
      the use of midazolam, the utilization of remimazolam resulted in an increase in 
      procedure success rate [odds ratio (OR) = 9.01, 95% confidence interval (CI): 
      2.35-34.57], a reduction in the application of rescue medication (OR = 13.58, 95% 
      CI: 3.46-53.28), a decrease in time to recovery [minutes, weighted mean 
      difference (WMD) = -5.70, 95% CI: -8.68 to -2.72], and a better cognitive 
      recovery of Hopkins Verbal Learning Test-Revised (WMD = 5.22, 95% CI: 2.88-7.55). 
      No difference was found in completion of procedure (OR = 1.68, 95% CI: 0.72-3.90) 
      with inconclusive in TSA. Despite no difference of total AEs (OR = 0.60, 95% CI: 
      0.24-1.50), more detailed analysis of AEs remained inconclusive in TSA. The GRADE 
      assessment demonstrated low to very low CoE. Conclusion: Our analysis suggested 
      that remimazolam may be a better choice for procedural sedation than midazolam. 
      Nevertheless, further studies are warranted to conclusively establish its safety.
CI  - Copyright (c) 2021 Jhuang, Yeh, Huang and Lai.
FAU - Jhuang, Bo-Jyun
AU  - Jhuang BJ
AD  - Department of Anesthesiology, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.
FAU - Yeh, Bo-Han
AU  - Yeh BH
AD  - Department of Anesthesiology, Linkou Medical Center, Chang Gung Memorial 
      Hospital, Taoyuan, Taiwan.
FAU - Huang, Yen-Ta
AU  - Huang YT
AD  - Department of Surgery, National Cheng Kung University Hospital, College of 
      Medicine, National Cheng Kung University, Tainan, Taiwan.
FAU - Lai, Pei-Chun
AU  - Lai PC
AD  - Education Center, National Cheng Kung University Hospital, College of Medicine, 
      National Cheng Kung University, Tainan, Taiwan.
LA  - eng
PT  - Systematic Review
DEP - 20210727
PL  - Switzerland
TA  - Front Med (Lausanne)
JT  - Frontiers in medicine
JID - 101648047
PMC - PMC8353129
OTO - NOTNLM
OT  - endoscopy
OT  - meta-analysis
OT  - procedural sedation
OT  - remimazolam
OT  - trial sequential analysis
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2021/08/14 06:00
MHDA- 2021/08/14 06:01
PMCR- 2021/07/27
CRDT- 2021/08/13 07:12
PHST- 2021/05/06 00:00 [received]
PHST- 2021/06/16 00:00 [accepted]
PHST- 2021/08/13 07:12 [entrez]
PHST- 2021/08/14 06:00 [pubmed]
PHST- 2021/08/14 06:01 [medline]
PHST- 2021/07/27 00:00 [pmc-release]
AID - 10.3389/fmed.2021.641866 [doi]
PST - epublish
SO  - Front Med (Lausanne). 2021 Jul 27;8:641866. doi: 10.3389/fmed.2021.641866. 
      eCollection 2021.