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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Merseyside
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Liverpool、Merseyside、イギリス、L12 2AP
- 募集
- Alder Hey Children's Hospital
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コンタクト：
- Phillip Arnold
- 電話番号：0151 228 4811
- メール：Philip.Arnold@alderhey.nhs.uk
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コンタクト：
- Syed Sanaulla
- 電話番号：0151 228 4811
- メール：Sanaulla.Syed@alderhey.nhs.uk
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主任研究者：
- Phillip Arnold
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主任研究者：
- Syed Sanaulla
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diaphragm movement
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Scan Quality
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
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研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
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最終確認日
詳しくは
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