Evidence map›Paper›PMID 32144789›Full record

ArticleBritish journal of clinical pharmacology2020

Potential strategy for assessing QT/QTc interval for drugs that produce rapid changes in heart rate: Electrocardiographic assessment of the effects of intravenous remimazolam on cardiac repolarization.

Robert B Kleiman, Borje Darpo, Michael Thorn, Thomas Stoehr, Frank Schippers

Open access · hybridAbstract read
In one paragraph

Article in British 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 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 11% 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

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. RemimazolamPeerJ · 2026
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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

5 authors at 3 institutions in 3 countries.

Robert B KleimaneResearch Technology, Philadelphia, PA, USA.ORCID 0000-0003-0333-9045
Borje DarpoeResearch Technology, Philadelphia, PA, USA.
Michael ThornStatistical Resources, Chapel Hill, NC, USA.
Thomas StoehrPaion Germany GmbH, Aachen, Germany.ORCID 0000-0001-7162-5786
Frank SchippersPaion Germany GmbH, Aachen, Germany.
ERT (Germany) · DEPaion (Germany) · DEStatistical and Applied Mathematical Sciences Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsRemimazolam is a new, ultra-short-acting benzodiazepine developed for intravenous (IV) use during procedural sedation and in general anaesthesia. Two trials were conducted to characterize its effects on cardiac repolarization.

methodsA thorough QT/QTc (TQT) study assessed electrocardiography effects of therapeutic and supratherapeutic doses of remimazolam and midazolam. To investigate whether RR-QT hysteresis effects due to rapid heart rate changes might have confounded the QTc assessments in the TQT trial, a second trial used continuous IV remimazolam infusion to achieve stable heart rates during periods of stable remimazolam plasma concentration.

resultsDuring the TQT, both compounds produced a 10-20-beats/min increase in heart rate within 30 seconds, persisting for 5-10 minutes. Within 30 seconds, the upper bound of the 2-sided 90% confidence interval for the placebo-corrected change from baseline for QTcI (ΔΔQTcI) exceeded 10 ms for both doses of remimazolam (ΔΔQTcI 7.2 [3.2, 11.2] ms for the 10 mg dose and 10.4 [6.5, 14.3] ms for the 20 mg dose) as well as for the 7.5-mg dose of midazolam (8.2 [4.4, 12.1] ms). At 2 minutes after IV bolus, the upper bound of the 2-sided 90% confidence interval for ΔΔQTcI exceeded 10 ms only for the remimazolam 20-mg dose (6.3 [2.3, 10.2] ms). During the second study, during periods of stable heart rate, remimazolam had no clinically significant effect on QTc (peak ΔΔQTcI 3.4 [-1.1, 7.6] ms).

conclusionRemimazolam does not prolong cardiac repolarization (QTc). The methods reported here may allow assessment of the QTc effects of other drugs given by IV bolus.

Indexed as

ElectrocardiographyPharmaceutical PreparationsBenzodiazepinesDose-Response Relationship, DrugDouble-Blind MethodHeart RateHumansBenzodiazepinesPharmaceutical Preparationsremimazolamintravenous drug administration, QT interval, QT-RR hysteresis

Identifiers

PMID32144789
PMCPMC7373701
OpenAlexW3010288055

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.