Study to Evaluate the Optimal Dose of Remifentanil During MRI of the Heart Under General Anaesthesia
Study to Evaluate the Optimal Dose of Remifentanil Required to Ensure Apnoea During Magnetic Resonance Imaging of the Heart Under General Anaesthesia
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Merseyside
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Liverpool, Merseyside, Vereinigtes Königreich, L12 2AP
- Rekrutierung
- Alder Hey Children's Hospital
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Kontakt:
- Phillip Arnold
- Telefonnummer: 0151 228 4811
- E-Mail: Philip.Arnold@alderhey.nhs.uk
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Kontakt:
- Syed Sanaulla
- Telefonnummer: 0151 228 4811
- E-Mail: Sanaulla.Syed@alderhey.nhs.uk
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Hauptermittler:
- Phillip Arnold
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Hauptermittler:
- Syed Sanaulla
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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. |
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
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Diaphragm movement
Zeitfenster: 30 seconds
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The primary outcome will be movement of the diaphragm during the single test apnoea. The dose of remifentanil will be judged:
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30 seconds
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Scan Quality
Zeitfenster: 1 hour
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• quality of the scan from the respiratory gated sequence (graded by the radiologist who will be blinded to the dose)
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1 hour
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Heart Rate
Zeitfenster: 1 hour
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• highest and lowest heart rate (during equilibrium and study period)
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1 hour
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Blood pressure
Zeitfenster: 1 hour
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• lowest blood pressure (during equilibrium and study period)
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1 hour
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Emergence time
Zeitfenster: 1 hour
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• time to emergence (waking up) at end of scan
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1 hour
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Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Syed SK, Corry P. Cardiac Imaging under general anaesthesia for children with congenital heart disease. Our experience. Abstract presentation, APAGBI scientific meeting. 2012.
- Chanavaz C, Tirel O, Wodey E, Bansard JY, Senhadji L, Robert JC, Ecoffey C. Haemodynamic effects of remifentanil in children with and without intravenous atropine. An echocardiographic study. Br J Anaesth. 2005 Jan;94(1):74-9. doi: 10.1093/bja/aeh293. Epub 2004 Oct 14.
- Crawford MW, Hayes J, Tan JM. Dose-response of remifentanil for tracheal intubation in infants. Anesth Analg. 2005 Jun;100(6):1599-1604. doi: 10.1213/01.ANE.0000150940.57369.B5.
- Hume-Smith H, McCormack J, Montgomery C, Brant R, Malherbe S, Mehta D, Ansermino JM. The effect of age on the dose of remifentanil for tracheal intubation in infants and children. Paediatr Anaesth. 2010 Jan;20(1):19-27. doi: 10.1111/j.1460-9592.2009.03190.x. Epub 2009 Nov 23.
- Min SK, Kwak YL, Park SY, Kim JS, Kim JY. The optimal dose of remifentanil for intubation during sevoflurane induction without neuromuscular blockade in children. Anaesthesia. 2007 May;62(5):446-50. doi: 10.1111/j.1365-2044.2007.05037.x.
- Ross AK, Davis PJ, Dear Gd GL, Ginsberg B, McGowan FX, Stiller RD, Henson LG, Huffman C, Muir KT. Pharmacokinetics of remifentanil in anesthetized pediatric patients undergoing elective surgery or diagnostic procedures. Anesth Analg. 2001 Dec;93(6):1393-401, table of contents. doi: 10.1097/00000539-200112000-00008.
- Whitehead J, Brunier H. Bayesian decision procedures for dose determining experiments. Stat Med. 1995 May 15-30;14(9-10):885-93; discussion 895-9. doi: 10.1002/sim.4780140904.
- Whitehead J, Williamson D. Bayesian decision procedures based on logistic regression models for dose-finding studies. J Biopharm Stat. 1998 Jul;8(3):445-67. doi: 10.1080/10543409808835252.
- Zhou Y, Whitehead J. Practical Implementation of Bayesian Dose-Escalation Procedures. Drug Information Journal. 2003;37(1):45-59.
- R Core Team R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2013.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Herz-Kreislauf-Erkrankungen
- Herzkrankheiten
- Physiologische Wirkungen von Arzneimitteln
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Anästhetika, intravenös
- Anästhesie, Allgemein
- Anästhetika
- Analgetika, Opioide
- Betäubungsmittel
- Hypnotika und Beruhigungsmittel
- Remifentanil
- Propofol
Andere Studien-ID-Nummern
- 146613
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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