Evidence map›Paper›PMID 41373030›Full record

ArticleJournal of intensive care2025

Prolonged infusion of remimazolam in surgical and medical intensive care unit patients: a pilot pharmacokinetic study.

Yuji Suzuki, Matsuyuki Doi, Yoshitaka Aoki, Hiromi Kato, Kensuke Kobayashi, Soichiro Mimuro, Takashi Mochizuki, Takahiro Yamada, Motoyasu Miura, Shinya Uchida and 1 more

Abstract read
In one paragraph

Article in Journal of intensive care, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Yuji SuzukiDepartment of Intensive Care Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan. alutena@gmail.com.ORCID http://orcid.org/0000-0003-1156-3311
Matsuyuki DoiDepartment of Intensive Care Medicine, Hamamatsu Medical Center, Hamamatsu, Japan.
Yoshitaka AokiDepartment of Intensive Care Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Hiromi KatoDepartment of Intensive Care Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Kensuke KobayashiDepartment of Intensive Care Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Soichiro MimuroDepartment of Intensive Care Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Takashi MochizukiDepartment of Hospital Pharmacy, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Takahiro YamadaDepartment of Hospital Pharmacy, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Motoyasu MiuraDepartments of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Shinya UchidaDepartments of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, Shizuoka, Japan.
Yoshiki NakajimaDepartment of Intensive Care Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.

Funding

JSPS KAKENHI JP 22K09116
6 · The paper itself

Abstract

backgroundThe pharmacokinetics of prolonged remimazolam infusion in patients undergoing long-term mechanical ventilation remain unclear. This study aimed to evaluate the pharmacokinetics of remimazolam administered continuously for 24 h.

methodsThis open-label pharmacokinetic analysis enrolled patients requiring mechanical ventilation into two groups: the surgical group, which received remimazolam during and after surgery, and the medical ICU group, which received remimazolam in the intensive care unit (ICU). Remimazolam was administered at a fixed rate of 0.1 mg/kg/h for ≥ 24 h, and blood samples were collected at regular intervals. Plasma remimazolam concentrations were measured by tandem mass spectrometry.

resultsTwenty patients (10 in each group) completed the study. The median duration of remimazolam infusion was 24.0 h in the surgical group and 102.0 h in the medical ICU group. The steady-state plasma concentrations in both the surgical and medical ICU groups exhibited modest intrasubject variability (4.46-32.73%) and moderate intersubject variability (16.45-31.71%), with all values falling within clinically acceptable intermediate ranges. The plasma remimazolam concentration at the end of infusion was 130.7 ng/mL (95% confidence interval [CI] 115.2-146.1) in the surgical group and 134.3 ng/mL (95% CI 98.7-170.0) in the medical ICU group. Noncompartmental analysis showed that the clearance was 54.3 L/h (95% CI 47.6-61.8) and 55.6 L/h (95% CI 42.8-72.1) (P = 0.856), while the volume of distribution at steady state was 284 L (95% CI 215-376) and 316 L (95% CI 142-707) (P = 0.780), with no statistically significant differences between the groups.

conclusionsIn this preliminary study, both the surgical ICU group (approximately 24 h) and the medical ICU group (beyond 24 h) showed no evidence of time-dependent accumulation of plasma remimazolam, indicating a generally stable pharmacokinetic profile under the examined conditions.

trial registrationIn compliance with the Japanese Clinical Trials Act, the study was classified as a Specified Clinical Trial owing to the use of unapproved pharmaceuticals, which were reviewed by a certified review board (CRB) and registered in the Japan Registry of Clinical Trials (jRCTs041200076) on December 15, 2020.

Indexed as

BenzodiazepinesContinuous infusionDrug ClearanceIntensive care unitsIntra- and intersubject variabilityMechanical ventilationPharmacokineticsRemimazolamSedative agentsVolume of distribution

Identifiers

PMID41373030
PMCPMC12805780

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.