PMID- 32303884
OWN - NLM
STAT- MEDLINE
DCOM- 20210129
LR  - 20210608
IS  - 1438-8359 (Electronic)
IS  - 0913-8668 (Linking)
VI  - 34
IP  - 4
DP  - 2020 Aug
TI  - Safety and efficacy of remimazolam in induction and maintenance of general 
      anesthesia in high-risk surgical patients (ASA Class III): results of a 
      multicenter, randomized, double-blind, parallel-group comparative trial.
PG  - 491-501
LID - 10.1007/s00540-020-02776-w [doi]
AB  - PURPOSE: Remimazolam, an ultra-short-acting benzodiazepine sedative is equally 
      effective as propofol in induction and maintenance of general anesthesia with 
      improved hemodynamic stability in American Society of Anesthesiologists (ASA) 
      Class I and II patients. This trial investigated remimazolam's efficacy and 
      safety in vulnerable patients (ASA Class III) undergoing elective general 
      surgery. METHODS: A multicenter, randomized, double-blind, parallel-group trial 
      in 67 adult surgical patients undergoing general anesthesia with two remimazolam 
      induction doses (6 mg kg(-1) h(-1)-group A and 12 mg kg(-1) h(-1)-group B) has 
      been conducted in 6 trials sites in Japan. Remimazolam was infused up to 
      2 mg kg(-1) h(-1) for maintenance of anesthesia in both groups. RESULTS: The 
      functional anesthetic capability of the investigated drug was 100% in both arms. 
      The mean time to loss of consciousness (LoC) was significantly shorter in group B 
      (81.7 s) compared to group A (97.2 s), p = 0.0139. The mean bispectral index 
      (BIS) value during maintenance of anesthesia ranged from 46.0 to 68.0 and from 
      44.7 to 67.5 in group A and B, respectively. There was no statistically 
      significant difference between the remimazolam arms concerning the incidence of 
      blood pressure (BP) decrease (67.7% in group B vs. 54.8% in group A), recovery 
      profile or the incidence or severity of adverse events (AEs) or adverse drug 
      reactions (ADRs). CONCLUSION: Both induction regimens (6 and 12 mg kg(-1) h(-1)) 
      were equally efficacious and safe in surgical patients ASA Class III. A 
      significantly shorter time to LoC was observed with the higher remimazolam 
      dosage. Clinical trial registration This trial is registered with the Japan 
      Pharmaceutical Information Center-Clinical Trials Information (JapicCTI). 
      JapicCTI number: 121977.
FAU - Doi, Matsuyuki
AU  - Doi M
AD  - Department of Anesthesiology and Intensive Care, Hamamatsu University Hospital, 
      1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan. 
      matsuyuki_doi@nifty.com.
FAU - Hirata, Naoyuki
AU  - Hirata N
AD  - Department of Anesthesiology, Sapporo Medical University School of Medicine, 
      Sapporo, Japan.
FAU - Suzuki, Toshiyasu
AU  - Suzuki T
AD  - Department of Anesthesiology, Tokai University of Medicine, Isehara, Japan.
FAU - Morisaki, Hiroshi
AU  - Morisaki H
AD  - Department of Anesthesiology, Keio University School of Medicine, Tokyo, Japan.
FAU - Morimatsu, Hiroshi
AU  - Morimatsu H
AD  - Department of Anesthesiology and Resuscitology, Okayama University Hospital, 
      Okayama, Japan.
FAU - Sakamoto, Atsuhiro
AU  - Sakamoto A
AD  - Department of Anesthesiology, Nippon Medical School, Tokyo, Japan.
LA  - eng
SI  - JapicCTI/121977
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200417
PL  - Japan
TA  - J Anesth
JT  - Journal of anesthesia
JID - 8905667
RN  - 0 (Hypnotics and Sedatives)
RN  - 12794-10-4 (Benzodiazepines)
RN  - 7V4A8U16MB (remimazolam)
RN  - R60L0SM5BC (Midazolam)
RN  - YI7VU623SF (Propofol)
SB  - IM
MH  - Adult
MH  - Anesthesia, General/adverse effects
MH  - Benzodiazepines
MH  - Double-Blind Method
MH  - Humans
MH  - Hypnotics and Sedatives
MH  - Japan
MH  - Maintenance
MH  - *Midazolam/adverse effects
MH  - *Propofol/adverse effects
OTO - NOTNLM
OT  - ASA 3
OT  - CNS7056
OT  - General anesthesia
OT  - ONO-2745
OT  - Remimazolam
EDAT- 2020/04/19 06:00
MHDA- 2021/01/30 06:00
CRDT- 2020/04/19 06:00
PHST- 2019/11/19 00:00 [received]
PHST- 2020/04/04 00:00 [accepted]
PHST- 2020/04/19 06:00 [pubmed]
PHST- 2021/01/30 06:00 [medline]
PHST- 2020/04/19 06:00 [entrez]
AID - 10.1007/s00540-020-02776-w [pii]
AID - 10.1007/s00540-020-02776-w [doi]
PST - ppublish
SO  - J Anesth. 2020 Aug;34(4):491-501. doi: 10.1007/s00540-020-02776-w. Epub 2020 Apr 
      17.