Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children

5. september 2018 opdateret af: Jin Dong Liu, Xuzhou Medical University

Effect of Single-dose Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes After Sevoflurane Anesthesia in Children

Emergence agitation (EA) is a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying, moaning, or incoherent. Although usually transient, it is not only an extremely distressing event for children, parents, and staff, but may also result in self-injury or the need for restraint. The prevalence in children appears to be between 10% and 80% depending upon the definition and measurement tools used and is more frequently observed in the pre-school age-group. A clear correlation has been found between EA and negative postoperative behavioral changes, including anxiety, eating and sleeping disorders, enuresis, fear of darkness, that may persist for an extended period of time affecting emotional and cognitive development.Currently, numerous interventions have been studied to manage EA after surgery. Among them, dexmedetomidine (DEX) as a kind of highly selective α2 adrenergic receptor agonist has been done to reduce EA in children. Unfortunately, no studies examined posthospitalization negative behaviour changes.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The high incidence of EA and postoperative behavioural changes has encouraged paediatric anaesthetists and researchers to study methods to improve the perioperative care of children. Dexmedetomidine is a selective alpha-2 receptor agonist with properties that make it attractive to pediatric use. It provides sedation and anxiolysis acting on these receptors in the locus ceruleus of the pons. It also exerts dose-dependent moderate primary analgesic effects through activation of alpha-2 adrenoreceptors in the dorsal spinal horn causing a subsequent decrease in substance P release. The study aims to explore whether a single low-dose dexmedetomidine in the perioperative period has a preventive effect on EA in children, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization behavioural changes.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

96

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Jiangsu
      • Xuzhou, Jiangsu, Kina
        • The Affiliated Hospital of Xuzhou Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

2 år til 7 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age between 2-7 years old
  2. American Society of Anesthesiologists（ASA） score of I or II
  3. Selective ear, nose, and throat surgery under general anaesthesia with sevoflurane

Exclusion Criteria:

  1. Emergency surgery
  2. were intubated before induction of anaesthesia or not planned for extubation after anaesthesia
  3. had critical illness with haemodynamic instability, active bleeding, cancer, cardiac diseases including arrhythmias, malignant hyperthermia
  4. intellectual disability, or neurological illness with agitation-like symptoms
  5. weighed more than 50 kg
  6. were allergic to dexmedetomidine
  7. The use of sedative or analgesic medications before surgery

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dexmedetomidine group
the children received 0.5 μg/kg of intravenous dexmedetomidine over 10 minutes after induction of anesthesia
Medicin: Dexmedetomidine
Children in Dexmedetomidine group receive intravenous dexmedetomidine 0.5 ug/kg over 10 minutes after induction of anesthesia.
Placebo komparator: Control Comparator group
the children received 10ml saline over 10 minutes after induction of anesthesia
Medicin: saline
Children in Control Comparator group receive intravenous saline 10ml over 10 minutes after induction of anesthesia.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
Tidsramme: within 30 minutes after extubation in the post-anaesthesia care unit
Use the Pediatric Anesthesia Emergence Delirium (PAED) scale to record the incidence of EA.The score ranges from 0 to 20 points. A score of 10 or above is considered as EA.
within 30 minutes after extubation in the post-anaesthesia care unit

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain scores as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Tidsramme: within 30 minutes after extubation in the post-anaesthesia care unit
Use the Face, Legs, Activity, Cry, Consolability (FLACC) scale to record the pain scores. The score ranges from 0 to 10 points. A score of 4 or above is considered as pain.
within 30 minutes after extubation in the post-anaesthesia care unit
Rescue analgesia and sedative drug consumption
Tidsramme: within 30 minutes after extubation in the post-anaesthesia care unit
Rescue analgesia and sedative drug consumption in the post-anaesthesia care unit
within 30 minutes after extubation in the post-anaesthesia care unit
Incidence of adverse events
Tidsramme: within 30 minutes after extubation in the post-anaesthesia care unit
Incidence of adverse events in the post-anaesthesia care unit
within 30 minutes after extubation in the post-anaesthesia care unit
Post-hospitalization negative behaviour changes as assessed by the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale
Tidsramme: 1 day, 2 days,30 days post surgery
Use the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale to record the incidence of Post-hospitalization negative behaviour changes.This consists of 27 items describing six subscales: general anxiety, separation anxiety, sleep anxiety, eating disturbances, aggression against authority and apathy/withdrawal.The possible answers were provided on a scale from 1 to 5 ('much less', 'less', 'unchanged', 'more' or 'much more' than before hospitalisation).A score of 0 was awarded if no negative behaviour was reported either before or after surgery.Total score was calculated by adding up all responses.
1 day, 2 days,30 days post surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xuzhou Medical University

Efterforskere

  • Ledende efterforsker: Jin Dong Liu, M.S, The Affiliated Hospital of Xuzhou Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. september 2018

Primær færdiggørelse (Forventet)

1. juni 2019

Studieafslutning (Forventet)

1. juli 2019

Datoer for studieregistrering

Først indsendt

20. juni 2018

Først indsendt, der opfyldte QC-kriterier

12. juli 2018

Først opslået (Faktiske)

24. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • XYFY-2018-0061

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual Participant Data(IPD) will be available when this trial is finished and the article have been published

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Emergence Agitation

Kliniske forsøg med Dexmedetomidine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Liberia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner