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

This study is currently recruiting participants.
Verified January 2017 by Alder Hey Children's NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481791
First Posted: June 25, 2015
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Alder Hey Children's NHS Foundation Trust
  Purpose
What is the optimal maintenance dose of remifentanil to ensure apnoea, during breath hold episodes in children having cardiac MR imaging with general anaesthesia?

Condition Intervention Phase
Children Heart Diseases Anaesthesia Magnetic Resonance Imaging Drug: Remifentanil and/or propofol Drug: propofol Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study to Evaluate the Optimal Dose of Remifentanil Required to Ensure Apnoea During Magnetic Resonance Imaging of the Heart Under General Anaesthesia

Resource links provided by NLM:


Further study details as provided by Alder Hey Children's NHS Foundation Trust:

Primary Outcome Measures:
  • Diaphragm movement [ Time Frame: 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.


Secondary Outcome Measures:
  • Scan Quality [ Time Frame: 1 hour ]
    • quality of the scan from the respiratory gated sequence (graded by the radiologist who will be blinded to the dose)

  • Heart Rate [ Time Frame: 1 hour ]
    • highest and lowest heart rate (during equilibrium and study period)

  • Blood pressure [ Time Frame: 1 hour ]
    • lowest blood pressure (during equilibrium and study period)

  • Emergence time [ Time Frame: 1 hour ]
    • time to emergence (waking up) at end of scan


Estimated Enrollment: 35
Study Start Date: July 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: 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.
Drug: 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.
Drug: propofol
Equilibrium Period: During this period propofol will be infused at a constant rate of 100mcg/kg/min

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481791


Locations
United Kingdom
Alder Hey Children's Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Contact: Phillip Arnold    0151 228 4811    Philip.Arnold@alderhey.nhs.uk   
Contact: Syed Sanaulla    0151 228 4811    Sanaulla.Syed@alderhey.nhs.uk   
Principal Investigator: Phillip Arnold         
Principal Investigator: Syed Sanaulla         
Sponsors and Collaborators
Alder Hey Children's NHS Foundation Trust
  More Information

Publications:
Syed SK, Corry P. Cardiac Imaging under general anaesthesia for children with congenital heart disease. Our experience. Abstract presentation, APAGBI scientific meeting. 2012.
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.

Responsible Party: Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02481791     History of Changes
Other Study ID Numbers: 146613
First Submitted: June 19, 2015
First Posted: June 25, 2015
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Propofol
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents