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

January 9, 2019 updated by: 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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L12 2AP
        • Recruiting
        • Alder Hey Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Phillip Arnold
        • Principal Investigator:
          • Syed Sanaulla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 hour
Heart Rate
Time Frame: 1 hour
• highest and lowest heart rate (during equilibrium and study period)
1 hour
Blood pressure
Time Frame: 1 hour
• lowest blood pressure (during equilibrium and study period)
1 hour
Emergence time
Time Frame: 1 hour
• time to emergence (waking up) at end of scan
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alder Hey Children's NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146613

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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