Evidence map›Paper›PMID 32245513›Full record

ArticleTrials2020

Effect of xenon and dexmedetomidine as adjuncts for general anesthesia on postoperative emergence delirium after elective cardiac catheterization in children: study protocol for a randomized, controlled, pilot trial.

Sarah Devroe, Lisa Devriese, Frederik Debuck, Steffen Fieuws, Bjorn Cools, Marc Gewillig, Marc Van de Velde, Steffen Rex

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 34% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
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

8 authors at 1 institution in 1 country.

Sarah DevroeDepartment of Anesthesiology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. sarah.devroe@uzleuven.be.ORCID http://orcid.org/0000-0003-0931-7891
Lisa DevrieseDepartment of Anesthesiology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Frederik DebuckDepartment of Anesthesiology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Steffen FieuwsI-Biostat, KU Leuven - University of Leuven, Leuven, Belgium.
Bjorn CoolsDepartment of Pediatric and Congenital Cardiology, University Hospitals Leuven, Leuven, Belgium.
Marc GewilligDepartment of Pediatric and Congenital Cardiology, University Hospitals Leuven, Leuven, Belgium.
Marc Van de VeldeDepartment of Anesthesiology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
Steffen RexDepartment of Anesthesiology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium.
KU Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEmergence delirium, a manifestation of acute postoperative brain dysfunction, is frequently observed after pediatric anesthesia and has been associated with the use of sevoflurane. Both xenon and dexmedetomidine possess numerous desirable properties for the anesthesia of children with congenital heart disease, including hemodynamic stability, lack of neurotoxicity, and a reduced incidence of emergence delirium. Combining both drugs has never been studied as a balanced-anesthesia technique. This combination allows the provision of anesthesia without administering anesthetic drugs against which the Food and Drug Administration (FDA) issued a warning for the use in young children. METHODS/

designIn this phase-II, mono-center, prospective, single-blinded, randomized, controlled pilot trial, we will include a total of 80 children aged 0-3 years suffering from congenital heart disease and undergoing general anesthesia for elective diagnostic and/or interventional cardiac catheterization. Patients are randomized into two study groups, receiving either a combination of xenon and dexmedetomidine or mono-anesthesia with sevoflurane for the maintenance of anesthesia. The purpose of this study is to estimate the effect size for xenon-dexmedetomidine versus sevoflurane anesthesia with respect to the incidence of emergence delirium in children. We will also describe group differences for a variety of secondary outcome parameters including peri-interventional hemodynamics, emergence characteristics, incidence of postoperative vomiting, and the feasibility of a combined xenon-dexmedetomidine anesthesia in children. DISCUSSION: Sevoflurane is the most frequently used anesthetic in young children, but has been indicated as an independent risk factor in the development of emergence delirium. Xenon and dexmedetomidine have both been associated with a reduction in the incidence of emergence delirium. Combining xenon and dexmedetomidine has never been described as a balanced-anesthesia technique in children. Our pilot study will therefore deliver important data required for future prospective clinical trials.

trial registrationEudraCT, 2018-002258-56. Registered on 20 August 2018. https://www.clinicaltrialsregister.eu.

Indexed as

Anesthesia, GeneralAnesthetics, CombinedAnesthetics, InhalationCardiac CatheterizationChild, PreschoolDexmedetomidineEmergence DeliriumHeart Defects, CongenitalHumansPilot ProjectsPostoperative ComplicationsProspective StudiesRandomized Controlled Trials as TopicSevofluraneXenonAnesthetics, CombinedAnesthetics, InhalationDexmedetomidineSevofluraneXenonAnestheticsDexmedetomidineEmergence deliriumInhalationPediatric anesthesiaSevofluraneXenon

Identifiers

PMID32245513
PMCPMC7126401
OpenAlexW3014132764

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.