Evidence map›Paper›PMID 34078591›Full record

Trial reportBMJ (Clinical research ed.)2021

Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial.

Karim Asehnoune, Charlene Le Moal, Gilles Lebuffe, Marguerite Le Penndu, Nolwen Chatel Josse, Matthieu Boisson, Thomas Lescot, Marion Faucher, Samir Jaber, Thomas Godet and 17 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
6.3field-weighted citation impact, top 3% 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.

NCT03218553 phase3completednot on this map

Effects of Perioperative Administration of Dexamethasone on Postoperative Complications and Mortality After Non-cardiac Major Surgery : a Randomized, Multicentre, Double Blind, Study

TypeinterventionalSponsorNantes University HospitalRan2017 to 2019Enrolled1,222ConditionsMajor Non-cardiac SurgeryArmsDexamethasone, Placebos
NCT05567094 phase4completednot on this mapstarted 2022, after this paper: background citation

The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

TypeinterventionalSponsorRuijin HospitalRan2022 to 2023Enrolled300ConditionsPancreaticoduodenectomyArmsDexamethasone, Saline placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  13. Multimodal Analgesia in the Aesthetic Plastic Surgery: Concepts and Strategies.Plastic and reconstructive surgery. Global open · 2022
    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

27 authors at 17 institutions in 2 countries.

Karim AsehnouneCHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu, Nantes, France karim.asehnoune@chu-nantes.fr.ORCID 0000-0003-1899-3517
Charlene Le MoalService d'Anesthésie, Centre Hospitalier Le Mans, Le Mans, France.
Gilles LebuffeCentre Hospitalier Universitaire (CHU) Lille, Pôle Anesthésie Réanimation, Lille, France.
Marguerite Le PennduCHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu, Nantes, France.
Nolwen Chatel JosseService d'Anesthésie, Hôpital Privé du Confluent, Nantes, France.
Matthieu BoissonCHU de Poitiers, Université de Poitiers, Service d'Anesthésie-Réanimation, Poitiers, France.
Thomas LescotHôpital Saint Antoine, Service d'Anesthésie Réanimation Chirurgicale, Assistance publique des hôpitaux de Paris, Paris, France.
Marion FaucherInstitut Paoli Calmette, Service d'Anesthésie, Marseille, France.
Samir JaberAnesthesia and Critical Care Department B, Saint Eloi Teaching Hospital, PhyMedExp, Centre Hospitalier Universitaire Montpellier, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France.
Thomas GodetService d'Anesthésie et Réanimation, Hôpital Estaing, CHU Clermont Ferrand, Clermont-Ferrand, France.
Marc LeoneDepartment of Anesthesiology and Critical Care Medicine, Hôpital Nord, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France.
Cyrus MotamedDépartement d'Anesthésie & VVC, Gustave Roussy Cancer Center, Villejuif, France.
Jean Stephane DavidService d'Anesthésie Réanimation, Groupe Hospitalier Sud, Civils de Lyon, Pierre Benite, France.
Raphael CinottiCHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôpital Guillaume et René Laennec, Saint-Herblain, France.
Younes El AmineCH Valenciennes, Service d'Anesthésie, Valenciennes, France.
Darius LiutkusService d'Anesthésie, Centre Hospitalier Le Mans, Le Mans, France.
Matthias GarotCentre Hospitalier Universitaire (CHU) Lille, Pôle Anesthésie Réanimation, Lille, France.
Antoine MarcCHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu, Nantes, France.
Anne Le CorreService d'Anesthésie, Hôpital Privé du Confluent, Nantes, France.
Alexandre ThomasseauCHU de Poitiers, Université de Poitiers, Service d'Anesthésie-Réanimation, Poitiers, France.
Alexandra JobertCHU de Nantes, Direction de la Recherche, Plateforme de Méthodologie et Biostatistique, Nantes, France.
Laurent FletCHU Nantes, Service Pharmacie, Hôtel Dieu, Nantes, France.
Fanny FeuilletUniversité de Nantes, Université de Tours, INSERM, SPHERE U1246, Nantes, France.
Morgane PereCHU de Nantes, Direction de la Recherche, Plateforme de Méthodologie et Biostatistique, Nantes, France.
Emmanuel FutierService d'Anesthésie et Réanimation, Hôpital Estaing, CHU Clermont Ferrand, Clermont-Ferrand, France.
Antoine RoquillyCHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu, Nantes, France.
PACMAN study group
Nantes Université · FRCentre d'Investigation Clinique de Nantes · FRCentre Hospitalier du Mans · FRCentre Hospitalier Universitaire de Clermont-Ferrand · FRCentre Hospitalier Universitaire de Lille · FRCentre Hospitalier Universitaire de Nantes · FRHôpital privé du Confluent · FRUniversité de Poitiers · FRAix-Marseille Université · FRCentre Hospitalier de Valenciennes · FRCentre National de la Recherche Scientifique · FRHôpital Laennec · FRHôpital Lyon Sud · FRInstitut Gustave Roussy · FRInstitut Paoli-Calmettes · FRSorbonne Université · FRUniversité de Tours · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery.

designPhase III, randomised, double blind, placebo controlled trial.

setting34 centres in France, December 2017 to March 2019.

participants1222 adults (>50 years) requiring major non-cardiac surgery with an expected duration of more than 90 minutes. The anticipated time frame for recruitment was 24 months.

interventionsParticipants were randomised to receive either dexamethasone (0.2 mg/kg immediately after the surgical procedure, and on day 1) or placebo. Randomisation was stratified on the two prespecified criteria of cancer and thoracic procedure. MAIN OUTCOMES MEASURES: The primary outcome was a composite of postoperative complications or all cause mortality within 14 days after surgery, assessed in the modified intention-to-treat population (at least one treatment administered).

resultsOf the 1222 participants who underwent randomisation, 1184 (96.9%) were included in the modified intention-to-treat population. 14 days after surgery, 101 of 595 participants (17.0%) in the dexamethasone group and 117 of 589 (19.9%) in the placebo group had complications or died (adjusted odds ratio 0.81, 95% confidence interval 0.60 to 1.08; P=0.15). In the stratum of participants who underwent non-thoracic surgery (n=1038), the primary outcome occurred in 69 of 520 participants (13.3%) in the dexamethasone group and 93 of 518 (18%) in the placebo group (adjusted odds ratio 0.70, 0.50 to 0.99). Adverse events were reported in 288 of 613 participants (47.0%) in the dexamethasone group and 296 of 609 (48.6%) in the placebo group (P=0.46).

conclusionsDexamethasone was not found to significantly reduce the incidence of complications and death in patients 14 days after major non-cardiac surgery. The 95% confidence interval for the main result was, however, wide and suggests the possibility of important clinical effectiveness.

trial registrationClinicalTrials.gov NCT03218553.

Indexed as

AgedAnti-Inflammatory AgentsDexamethasoneDouble-Blind MethodDrug Administration ScheduleFemaleFranceHumansIncidenceMaleMiddle AgedOperative TimePostoperative CarePostoperative ComplicationsAnti-Inflammatory AgentsDexamethasone

Identifiers

PMID34078591
PMCPMC8171383
OpenAlexW3165616089

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.