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Randomized Controlled Trial
. 2020 Aug;34(4):491-501.
doi: 10.1007/s00540-020-02776-w. Epub 2020 Apr 17.

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

Matsuyuki Doi  1 , Naoyuki Hirata  2 , Toshiyasu Suzuki  3 , Hiroshi Morisaki  4 , Hiroshi Morimatsu  5 , Atsuhiro Sakamoto  6
Affiliations
Randomized Controlled Trial

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

Matsuyuki Doi et al. J Anesth. 2020 Aug.

Abstract

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.

Keywords: ASA 3; CNS7056; General anesthesia; ONO-2745; Remimazolam.

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References

    1. Reves JG, Glass P, Lubarsky D, McEvoy M, Martinez-Ruiz R. Intravenous anesthetics. In: Miller RD, editor. Miller's anesthesia. 7th ed. San Francisco: Elsevier; 2010. p. 719–768. - DOI
    1. Shafer SL, Stanski DR. Intravenous anesthesia: techniques and new drugs; 1991. p. 7. https://triallib.net/doc/5828823/intravenous-anesthesia-1991 . Accessed Sep 26, 2018.
    1. Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD, Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002;30:119–41. - DOI
    1. Propofol side effects. https://www.drugs.com/sfx/propofol-side-effects.html . Accessed Sep 26, 2018.
    1. Valente JF, Anderson GL, Branson RD, Johnson DJ, Davis K Jr, Porembka DT. Disadvantages of prolonged propofol sedation in the critical care unit. Crit Care Med. 1994;22(4):710–2. - DOI

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