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Study to Evaluate the Optimal Dose of Remifentanil During MRI of the Heart Under General Anaesthesia

9. januar 2019 opdateret af: Alder Hey Children's NHS Foundation Trust

Study to Evaluate the Optimal Dose of Remifentanil Required to Ensure Apnoea During Magnetic Resonance Imaging of the Heart Under General Anaesthesia

What is the optimal maintenance dose of remifentanil to ensure apnoea, during breath hold episodes in children having cardiac MR imaging with general anaesthesia?

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The management of congenital heart disease depends upon accurate imaging of the heart to define anatomical abnormalities. The use of magnetic resonance imaging has grown in response to this need. Young children, however, are unable to cooperate sufficiently to allow the scan to occur; this necessitates the use of general anaesthesia.

The optimal anaesthetic management of children in this situation is complex. Imaging of an acceptable quality depends on a low (normal) heart rate which is relatively constant during the scan and frequent breath holds to avoid respiratory artefacts. Children undergoing such scans commonly have significant cardiac and non-cardiac disease. A technique, currently used at Alder Hey Hospital, is to use intravenous agents to provide anaesthesia: commonly a mixture of the intravenous anaesthetic propofol and the potent opiate remifentanil. The patient's own ventilation is suppressed by the use of remifentanil which also reduces heart rate and heart rate variability. Controlled ventilation is provided via a ventilator and endotracheal tube. Adequate doses of remifentanil are required to ensure suppression of the patient's ventilation whilst excess doses are avoided to reduce the risk of adverse effects (primarily arterial hypotension) and ensure rapid recovery.

Remifentanil dose has been studied during surgery(3-6), however this is a unique indication and optimal dosage has not been formally studied. In particular the absence of any stimulation from surgery is likely to mean that substantially lower doses of remifentanil will be required.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

35

Fase

  • Fase 3

Kontakter og lokationer

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Studiesteder

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

1 år til 7 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Children of one year (of age) or older and younger than 7 years of age.
  • Scheduled for cardiac MR imaging under general anaesthesia at Alder Hey Children's Hospital.
  • Parental Consent

Exclusion Criteria:

  • Hypersensitivity to any study drug
  • Known abnormal response to opiate analgesics or co-morbidity associated with abnormal central control of breathing
  • Families unable to understand or complete consent
  • Any other contraindication to proposed anaesthetic technique: at the discretion of the responsible anaesthetist.
  • Documented significant renal or hepatic dysfunction

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Remifentanil

Induction Phase: A dose of remifentanil 1mcg/kg by slow bolus, will be given to facilitate endotracheal intubation. Further doses of either remifentanil (0.5 mcg/kg) or propofol (1-2mg/kg) may be given to ensure an anaesthetised patient.

Settling Period: An infusion of the test dose of remifentanil will be commenced from an infusion prepared prior to the patient being anaesthetised. 1mg of Remifentanil (one vial) will be diluted to a volume of 50mls in normal saline 0.9% in a 50ml syringe. Maintenance dose of propofol 130 mcg/Kg/min for the first 5 minutes reduced to 100 mcg/kg/min thereafter. 40mls of propofol 1% (10mg/ml) will be drawn undiluted into a 50ml syringe. During the settling period further doses of either remifentanil (0.5 mcg/kg) or propofol (1-2mg/kg) may be given.

Equilibrium Period: During this period propofol will be infused at a constant rate of 100mcg/kg/min.
Medicin: Remifentanil and/or propofol
Induction Phase: A dose of remifentanil 1mcg/kg by slow bolus, will be given to facilitate endotracheal intubation. Further doses of either remifentanil (0.5 mcg/kg) or propofol (1-2mg/kg) may be given to ensure an anaesthetised patient.
Medicin: Remifentanil and/or propofol
Settling Period: An infusion of the test dose of remifentanil will be commenced from an infusion prepared prior to the patient being anaesthetised. 1mg of Remifentanil (one vial) will be diluted to a volume of 50mls in normal saline 0.9% in a 50ml syringe. Maintenance dose of propofol 130 mcg/Kg/min for the first 5 minutes reduced to 100 mcg/kg/min thereafter. 40mls of propofol 1% (10mg/ml) will be drawn undiluted into a 50ml syringe. During the settling period further doses of either remifentanil (0.5 mcg/kg) or propofol (1-2mg/kg) may be given.
Medicin: propofol
Equilibrium Period: During this period propofol will be infused at a constant rate of 100mcg/kg/min

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diaphragm movement
Tidsramme: 30 seconds

The primary outcome will be movement of the diaphragm during the single test apnoea. The dose of remifentanil will be judged:

  • A success. If no movement of the diaphragm is detected by MRI imaging during a 30 second test apnoea.
  • A failure. If movement of the diaphragm is detected during the test apnoea.
30 seconds

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Scan Quality
Tidsramme: 1 hour
• quality of the scan from the respiratory gated sequence (graded by the radiologist who will be blinded to the dose)
1 hour
Heart Rate
Tidsramme: 1 hour
• highest and lowest heart rate (during equilibrium and study period)
1 hour
Blood pressure
Tidsramme: 1 hour
• lowest blood pressure (during equilibrium and study period)
1 hour
Emergence time
Tidsramme: 1 hour
• time to emergence (waking up) at end of scan
1 hour

Samarbejdspartnere og efterforskere

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

Sponsor

Alder Hey Children's NHS Foundation Trust

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

1. juli 2015

Primær færdiggørelse (Forventet)

31. december 2019

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

19. juni 2015

Først indsendt, der opfyldte QC-kriterier

23. juni 2015

Først opslået (Skøn)

25. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 146613

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hjertesygdomme

Kliniske forsøg med Remifentanil and/or propofol

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