Evidence map›Paper›PMID 33243149›Full record

ArticleBMC anesthesiology2020

Determination of the ED95 of intrathecal hyperbaric prilocaine with sufentanil for scheduled cesarean delivery: a dose-finding study based on the continual reassessment method.

P Goffard, Y Vercruysse, R Leloup, J-F Fils, S Chevret, Y Kapessidou

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC anesthesiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03036384 (Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 25% 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.

NCT03036384 phase2completednot on this map

Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery : a Dose-finding Study Bases on the Continual Reassessment Method (CRM)

TypeinterventionalSponsorCentre Hospitalier Universitaire Saint PierreRan2016 to 2016Enrolled40ConditionsPregnant WomenArmsHB Prilocaine 2% (varying dose), HB Prilocaine 2%, Sufentanil, Morphine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
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

6 authors at 3 institutions in 2 countries.

P GoffardDepartment of Anesthesiology, University Hospital Saint Pierre, Université Libre de Bruxelles, CHU Saint-Pierre, Rue Haute 322, 1000, Brussels, Belgium.
Y VercruysseDepartment of Anesthesiology, University Hospital Saint Pierre, Université Libre de Bruxelles, CHU Saint-Pierre, Rue Haute 322, 1000, Brussels, Belgium. yoann.vercruysse@ulb.be.ORCID 0000-0001-5093-2568
R LeloupDepartment of Anesthesiology, University Hospital Saint Pierre, Université Libre de Bruxelles, CHU Saint-Pierre, Rue Haute 322, 1000, Brussels, Belgium.
J-F FilsArs Statistica S.P.R.L, Nivelles, Belgium.
S ChevretService de Biostatistique et Information Médicale, Hôpital Saint-Louis, Paris, France.
Y KapessidouDepartment of Anesthesiology, University Hospital Saint Pierre, Université Libre de Bruxelles, CHU Saint-Pierre, Rue Haute 322, 1000, Brussels, Belgium.
Université Libre de Bruxelles · BEHôpital Saint-Louis · FRStatistics Belgium · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundScheduled cesarean section is routinely performed under spinal anesthesia using hyperbaric bupivacaine. The current study was undertaken to determine the clinically relevant 95% effective dose of intrathecal 2% hyperbaric prilocaine co-administered with sufentanil for scheduled cesarean section, using continual reassessment method.

methodsWe conducted a dose-response, prospective, double-blinded study to determine the ED95 values of intrathecal hyperbaric prilocaine used with 2,5 mcg of sufentanil and 100 mcg of morphine for cesarean delivery. Each parturient enrolled in the study received an intrathecal dose of hyperbaric prilocaine determined by the CRM and the success or failure of the block was assessed as being the primary endpoint.

resultsThe doses given for each cohort varied from 35 to 50 mg of HP, according to the CRM, with a final ED95 lying between 45 and 50 mg of Prilocaine after completion of the 10 cohorts. Few side effects were reported and patients were globally satisfied.

conclusionsThe ED95 of intrathecal hyperbaric prilocaine with sufentanil 2.5 μg and morphine 100 μg for elective cesarean delivery was found to be between 45 and 50 mg. It may be an interesting alternative to other long-lasting local anesthetics in this context.

trial registrationThe study was registered on January 30, 2017 - retrospectively registered - and results posted at the public database clinicaltrials.gov ( NCT03036384 ).

Indexed as

AdultAnalgesics, OpioidAnesthesia, ObstetricalAnesthesia, SpinalAnesthetics, LocalCesarean SectionDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansPregnancyPrilocaineProspective StudiesSufentanilAnalgesics, OpioidAnesthetics, LocalPrilocaineSufentanilCesarean sectionContinual reassessment methodED95Hyperbaric prilocaineSufentanil

Identifiers

PMID33243149
PMCPMC7690017
OpenAlexW3110162734

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

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.