Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial

Doi, Matsuyuki; Morita, Kiyoshi; Takeda, Junzo; Sakamoto, Atsuhiro; Yamakage, Michiaki; Suzuki, Toshiyasu

doi:10.1007/s00540-020-02788-6

Cited by 296 publications

(439 citation statements)

References 16 publications

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“…In this case, the patient fully awoke and was able to perform intraoperative language tasks during the AC. We suggest remimazolam to be an alternative option for general anesthesia for AC; it is an ultrashortacting agent, and if delayed arousal occurred, flumazenil can be administered as an antagonist [1,6].…”

Section: Takehito Sato * Yumi Kato Mayumi Yamamoto and Kimitoshi Nmentioning

confidence: 99%

Novel anesthetic agent remimazolam as an alternative for the asleep-awake-asleep technique of awake craniotomy

et al. 2020

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Section: Takehito Sato * Yumi Kato Mayumi Yamamoto and Kimitoshi Nmentioning

confidence: 99%

Novel anesthetic agent remimazolam as an alternative for the asleep-awake-asleep technique of awake craniotomy

et al. 2020

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“…The patient lost consciousness after a 1-min infusion of 6 mg/kg/h of remimazolam. In a previous phase II trial [6], the mean time of the loss in consciousness with 6 mg/kg/h remimazolam was 102 s. In this case, the dose of remimazolam for induction was smaller than the dose in the phase II trial. During the procedure, the infusion rate was approximately 1/4 of the standard infusion rate, as indexed by BIS.…”

Section: Discussionmentioning

confidence: 65%

Anesthetic management for a patient with myotonic dystrophy with remimazolam

2021

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Background Patients with myotonic dystrophy may have increased sensitivity to drugs used for anesthesia. We successfully managed general anesthesia in a patient with myotonic dystrophy using a novel intravenous anesthetic, remimazolam. Case presentation The patient was a 46-year-old man, 169 cm in height, and weighing 60 kg. He was diagnosed with myotonic dystrophy 5 years previously. Phacoemulsification for both eyes was scheduled under general anesthesia. Anesthesia was induced with remimazolam 6 mg/kg/h for 1 min and maintained by continuous infusion at 0.25 mg/kg/h during surgery, a 1/4 dose of the standard infusion rate, as indexed by a bispectral index (BIS). Six minutes after remimazolam discontinuation, the patient opened his eyes on verbal command with sufficient spontaneous respiration. Flumazenil (0.2 mg) was administered to boost the patient’s recovery. Conclusion In addition to the short-acting anesthetic remimazolam, the presence of the antagonist flumazenil enabled complete recovery from anesthesia, without postoperative complications.

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“…pharmacodynamic (PopPK/PD 3 ) analysis pooled data across studies in healthy volunteers, 1,4,5 surgical patients, 4,[6][7][8] procedural sedation patients, 9,10 and patients in the intensive care unit. 11 There was high interindividual variability (IIV, 87%) in the volume of the central compartment (V1) likely due to the imprecise calculation of V1 after i.v.…”

Section: Remimazolam Poppk In Procedural Sedationmentioning

confidence: 99%

Population Pharmacokinetics of Remimazolam in Procedural Sedation With Nonhomogeneously Mixed Arterial and Venous Concentrations

Zhou¹,

Curd²,

Lohmer³

et al. 2020

Clinical Translational Sci

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Remimazolam is an ultra-short acting benzodiazepine under development for procedural sedation and general anesthesia. Population pharmacokinetic analysis (PopPK) was conducted for remimazolam with arterial and venous samples previously, but results were limited by arterial-venous concentration differences and inaccurate central volume of distribution (V1) estimates. A new model was developed to describe covariate effects after accounting for arterial-venous differences. Arterial and venous plasma concentration-time data from 11 clinical trials were pooled for PopPK. Data from two constant-rate infusion studies were used to account for venous-to-arterial (VtoA) ratio within residual error and to accurately estimate V1. V1 and VtoA ratio from the pilot model were applied to the full dataset, where the optimal fixed/random effects and covariates were assessed. VtoA ratio was described using a maximum effect (E max) model during infusion and as a constant postdose. V1 was estimated as 4.83 L for a 70 kg subject and interindividual variability (IIV) on V1 could only be estimated in studies with early concentrations. IIV on clearance was low (22.9%). Covariates included effects of sex on clearance (women 10% > men), and race on clearance and steady-state volume of distribution (African Americans 16% < other races). Arterialvenous concentration differences were best described using an E max model during infusion with a constant ratio after infusion, resulting in low residual error (20.7%). There are no clinically relevant dose adjustments needed for any covariates based on pharmacokinetic differences. www.cts-journal.com Remimazolam PopPK in Procedural Sedation Zhou et al.

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Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial

Cited by 296 publications

References 16 publications

Novel anesthetic agent remimazolam as an alternative for the asleep-awake-asleep technique of awake craniotomy

Novel anesthetic agent remimazolam as an alternative for the asleep-awake-asleep technique of awake craniotomy

Anesthetic management for a patient with myotonic dystrophy with remimazolam

Population Pharmacokinetics of Remimazolam in Procedural Sedation With Nonhomogeneously Mixed Arterial and Venous Concentrations

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