PMID- 36920745
OWN - NLM
STAT- MEDLINE
DCOM- 20230517
LR  - 20230822
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 40
IP  - 5
DP  - 2023 May
TI  - Study Protocol of a Multicenter, Randomized, Single-Blind Trial: Efficacy and 
      Safety of Remimazolam Tosylate for Sedation in ICU Patients.
PG  - 2524-2533
LID - 10.1007/s12325-023-02456-7 [doi]
AB  - INTRODUCTION: Pharmacodynamic and pharmacokinetic studies in animal experiments 
      and a phase 1 study suggested remimazolam tosylate as an effective and safe 
      sedation/anesthetic agent. However, the effects and safety dose of remimazolam 
      for light sedation in intensive care unit (ICU) patients are not clear and should 
      be confirmed in a phase 2 study. METHODS: Sixty ICU patients requiring sedation 
      treatment and undergoing mechanical ventilation will be enrolled and randomly 
      assigned to a high dose group (HD group, 30 cases) and a low dose group (LD 
      group, 30 cases) in a 1:1 ratio. Patients in both groups will be sedated using 
      remimazolam tosylate in a primary dose of 0.08 mg/kg and a range of 0-2.0 mg/kg/h 
      after randomization. Dose adjustment will be made at the range of every 
      0.1 mg/kg/h in the LD group and 0.2 mg/kg/h in the HD group to maintain the 
      target Richmond Agitation and Sedation Score (RASS) at - 2 to + 1. The primary 
      outcome will be the proportion of subjects that meet the following conditions: 
      the time within the range of RASS (- 2 to + 1) accounts for 70% of the study drug 
      administration time; without other rescue treatments. Secondary outcomes 
      including the percentage time to reach the sedation goal; the proportion of 
      subjects receiving rescue sedation and/or analgesic, and the mean dose of rescue 
      drug throughout the study period; duration of mechanical ventilation; recovery 
      time to full consciousness and nursing scores. Evaluations of safety including 
      adverse events (AEs), serious AEs, physical examination, laboratory examination, 
      etc. OUTCOME: The results of this study will provide crucial information for the 
      use of remimazolam tosylate for ICU sedation. TRIAL REGISTRATION: 
      ClinicalTrials.gov identifier, NCT05152303.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part 
      of Springer Nature.
FAU - Liu, Ning
AU  - Liu N
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Jiang, Zhiyi
AU  - Jiang Z
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Nie, Yao
AU  - Nie Y
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Zuo, Lingyun
AU  - Zuo L
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Chen, Chuanxi
AU  - Chen C
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Si, Xiang
AU  - Si X
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China.
FAU - Liu, Qin
AU  - Liu Q
AD  - Jiangsu Hengrui Pharmaceuticals Co., Ltd., No. 7 Kunlunshan Road, Economic and 
      Technological Development Area, Lianyungang, Jiangsu Province, China.
FAU - Chen, Minying
AU  - Chen M
AUID- ORCID: 0000-0001-7646-1311
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China. 
      chenminy@mail.sysu.edu.cn.
FAU - Guan, Xiangdong
AU  - Guan X
AD  - Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen 
      University, No. 58 Zhongshan 2nd Rd, Guangzhou, 510080, Guangdong, China. 
      guanxd@mail.sysu.edu.cn.
LA  - eng
SI  - ClinicalTrials.gov/NCT05152303
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230315
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 7V4A8U16MB (remimazolam)
RN  - 0 (Hypnotics and Sedatives)
RN  - 12794-10-4 (Benzodiazepines)
MH  - Humans
MH  - *Hypnotics and Sedatives/adverse effects
MH  - Single-Blind Method
MH  - *Benzodiazepines
MH  - Intensive Care Units
MH  - Randomized Controlled Trials as Topic
MH  - Multicenter Studies as Topic
OTO - NOTNLM
OT  - Dose-finding
OT  - Mechanical ventilation
OT  - Remimazolam tosylate
OT  - Sedation
EDAT- 2023/03/16 06:00
MHDA- 2023/05/17 06:42
CRDT- 2023/03/15 12:23
PHST- 2022/12/15 00:00 [received]
PHST- 2023/02/09 00:00 [accepted]
PHST- 2023/05/17 06:42 [medline]
PHST- 2023/03/16 06:00 [pubmed]
PHST- 2023/03/15 12:23 [entrez]
AID - 10.1007/s12325-023-02456-7 [pii]
AID - 10.1007/s12325-023-02456-7 [doi]
PST - ppublish
SO  - Adv Ther. 2023 May;40(5):2524-2533. doi: 10.1007/s12325-023-02456-7. Epub 2023 
      Mar 15.