Evidence map›Paper›PMID 31873765›Full record

Trial reportEuropean journal of clinical pharmacology2020

Safety, pharmacokinetic and pharmacodynamic properties of single ascending dose and continuous infusion of remimazolam besylate in healthy Chinese volunteers.

Xiao-Yan Sheng, Yan Liang, Xue-Yuan Yang, Li-E Li, Xia Ye, Xia Zhao, Yi-Min Cui

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 80 papers.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed
14.9field-weighted citation impact, top 1% of its field
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

80 citing papers in PubMed, 130 citations in OpenAlex.

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  6. Advantages of remimazolam for sedation in impacted tooth extraction.Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology · 2024
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  16. Remimazolam Tosilate Sedation with Adjuvant Sufentanil in Chinese Patients with Liver Cirrhosis Undergoing Gastroscopy: A Randomized Controlled Study.Medical science monitor : international medical journal of experimental and clinical research · 2022
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20 more citing papers are in PubMed but not listed here.

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

7 authors at 2 institutions in 1 country.

Xiao-Yan ShengDepartment of Pharmacy, Peking University First Hospital, No. 6, Da Hong Luo Chang Street, Xicheng District, Beijing, 100034, China.
Yan LiangDepartment of Pharmacy, Peking University First Hospital, No. 6, Da Hong Luo Chang Street, Xicheng District, Beijing, 100034, China.
Xue-Yuan YangDepartment of Anesthesiology, Peking University First Hospital, Beijing, China.
Li-E LiR&D, Yichang Humanwell Pharmaceutical Co. Ltd., Hubei, China.
Xia YeR&D, Yichang Humanwell Pharmaceutical Co. Ltd., Hubei, China.
Xia ZhaoDepartment of Pharmacy, Peking University First Hospital, No. 6, Da Hong Luo Chang Street, Xicheng District, Beijing, 100034, China.
Yi-Min CuiDepartment of Pharmacy, Peking University First Hospital, No. 6, Da Hong Luo Chang Street, Xicheng District, Beijing, 100034, China. cui.pharm@pkufh.com.ORCID http://orcid.org/0000-0002-4186-1005
Peking University · CNHumanwell Healthcare Group (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of the present study was to evaluate the safety, pharmacokinetic (PK) and pharmacodynamic (PD) properties of remimazolam besylate following single ascending dose (SAD) and continuous infusion in healthy Chinese volunteers.

methodsThis was a randomized phase I study conducted in two parts. Part I was a double-blind, placebo- and midazolam-controlled, SAD study among healthy Chinese participants with a remimazolam dose of 0.025-0.4 mg/kg. Part II was an open-label, midazolam-controlled, continuous infusion study. Bispectral index (BIS) monitoring and Modified Observers Assessment of Alertness and Sedation (MOAA/S) score assessment were used to assess the PD properties.

resultsThe half-life range of remimazolam was from 34.1 ± 8.1 to 59.8 ± 20.5 min in the SAD study. The sedation function was initially observed at the dose of 0.05 mg/kg remimazolam. Doses of ≥ 0.075 mg/kg exerted a peak sedation effect within 1-2 min after injection, resulting in a deeper and more rapid sedation. In the 2 h continuous infusion, remimazolam showed a deeper sedation and more rapid recovery than midazolam. For general anesthesia, an induction dosage of 0.2 mg/kg/min and a maintenance dosage of 1 mg/kg/h can achieve a satisfactory efficacy effect.

conclusionsRemimazolam was safe and well tolerated in healthy Chinese participants. Based on the phase I clinical study, we suggest that remimazolam besylate demonstrates greater sedation and quicker recovery from sedation than midazolam.

Indexed as

Dose-Response Relationship, DrugAdultAsian PeopleBenzodiazepinesDouble-Blind MethodFemaleHealthy VolunteersHumansHypnotics and SedativesInfusions, IntravenousMaleMidazolamYoung AdultBenzodiazepinesHypnotics and SedativesMidazolamremimazolamChinese subjectsPharmacodynamicsPharmacokineticsRemimazolam besylate

Identifiers

PMID31873765
OpenAlexW2996803040

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.