Evidence map›Paper›PMID 29236228›Full record

Trial reportClinical pharmacokinetics2018

Population Pharmacokinetic-Pharmacodynamic Modeling of Ropivacaine in Spinal Anesthesia.

Zoubir Djerada, Catherine Feliu, Yoann Cazaubon, Faouzi Smati, Philippe Gomis, Dominique Guerrot, Beny Charbit, Olivier Fernandes, Jean-Marc Malinovsky

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

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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

9 authors.

Zoubir DjeradaDepartment of Pharmacology, EA3801, SFR CAP-Santé, Reims University Hospital, 51, rue Cognacq-Jay, 51095, Reims Cedex, France. zoubir.djerada@univ-reims.fr.
Catherine FeliuDepartment of Pharmacology, EA3801, SFR CAP-Santé, Reims University Hospital, 51, rue Cognacq-Jay, 51095, Reims Cedex, France.
Yoann CazaubonDepartment of Pharmacology, EA3801, SFR CAP-Santé, Reims University Hospital, 51, rue Cognacq-Jay, 51095, Reims Cedex, France.
Faouzi SmatiDepartment of Anaesthesia and Intensive Care Pole URAD, Reims University Hospital, 45, rue Cognacq-Jay, 51092, Reims Cedex, France.
Philippe GomisDepartment of Anaesthesia and Intensive Care Pole URAD, Reims University Hospital, 45, rue Cognacq-Jay, 51092, Reims Cedex, France.
Dominique GuerrotDepartment of Nephrology and Transplantation, Centre, Rouen, France.
Beny CharbitDepartment of Anaesthesia and Intensive Care Pole URAD, Reims University Hospital, 45, rue Cognacq-Jay, 51092, Reims Cedex, France.
Olivier FernandesDepartment of Anaesthesia and Intensive Care Pole URAD, Reims University Hospital, 45, rue Cognacq-Jay, 51092, Reims Cedex, France.
Jean-Marc MalinovskyDepartment of Pharmacology, EA3801, SFR CAP-Santé, Reims University Hospital, 51, rue Cognacq-Jay, 51095, Reims Cedex, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRopivacaine is frequently used in spinal anesthesia but the relationship between plasma concentrations and sensory block level remains unknown.

objectiveThe aim of this study was to assess the relationship between plasma ropivacaine concentrations and effects during spinal anesthesia.

methodsSixty patients aged between 18 and 82 years were included in this study after providing written informed consent. Patients were randomly assigned to receive intrathecal administration of ropivacaine 15, 20 or 25 mg. Blood samples were drawn to determine ropivacaine concentrations, and sensory blockade was assessed using pinprick testing. Ropivacaine plasma concentrations and sensory block level were analyzed using a nonlinear mixed-effects modeling approach with Monolix 4.2.2. Uncertainty of parameters was estimated by bootstrapping.

resultsOverall, 216 plasma ropivacaine values and 407 sensory block-related data were available for pharmacokinetic-pharmacodynamic (PK-PD) model evaluation. A two-compartment open model connected to a spinal compartment was selected to describe the PKs of ropivacaine. Sensory block modeling was performed using a sigmoid E

conclusionsThis first population PK-PD model for ropivacaine in spinal anesthesia confirms the relationship between plasma ropivacaine concentrations and effect. We also clarify the relationship between the spread of sensory block level and dose, age and, for the first time, weight. STUDY REGISTRATION: This study was approved by the Reims University Hospital Ethics Committee (protocol: PHRC-2005; registered at Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM: D60890). This was an open, prospective, monocentric study conducted in the University Hospital of Reims (France).

Indexed as

Models, BiologicalAdolescentAdultAgedAged, 80 and overAge FactorsAnesthesia, SpinalAnesthetics, LocalDose-Response Relationship, DrugHumansInjections, SpinalMiddle AgedProspective StudiesRopivacaineYoung AdultAnesthetics, LocalRopivacaine

Identifiers

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.