NCT02481791

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

4.5 years

First QC Date

June 19, 2015

Last Update Submit

January 9, 2019

Conditions

ChildrenHeart DiseasesAnaesthesiaMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Diaphragm movement

    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 Outcomes (4)

  • Scan Quality

    1 hour

  • Heart Rate

    1 hour

  • Blood pressure

    1 hour

  • Emergence time

    1 hour

Study Arms (1)

Remifentanil

EXPERIMENTAL

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 propofolDrug: propofol

Interventions

Remifentanil and/or propofolDRUG

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.

Remifentanil
propofolDRUG

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

Remifentanil

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alder Hey Children's Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

RECRUITING

Related Publications (10)

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

    BACKGROUND

  • 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.

    PMID: 15486003BACKGROUND

  • 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.

    PMID: 15920180BACKGROUND

  • 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.

    PMID: 19968808BACKGROUND

  • 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.

    PMID: 17448054BACKGROUND

  • 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.

    PMID: 11726413BACKGROUND

  • 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.

    PMID: 7569508BACKGROUND

  • 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.

    PMID: 9741859BACKGROUND

  • Zhou Y, Whitehead J. Practical Implementation of Bayesian Dose-Escalation Procedures. Drug Information Journal. 2003;37(1):45-59.

    BACKGROUND

  • R Core Team R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2013.

    BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Interventions

Propofol

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 25, 2015

Study Start

July 1, 2015

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

GB(1)