Effect of Remifentanil Boluses on Hemodynamics in Skull Pin Insertion
The Dose Effects of Remifentanil Boluses on the Hemodynamic Response to Skull Pin Insertion.
調査の概要
詳細な説明
Skull pin insertion is commonly required for craniotomies and cervical spine surgery. It is a brief but highly stimulating maneuver performed following induction, during a period of light anesthesia, and may cause significant rise in blood pressure, heart rate and intracranial pressure if not anticipated and treated.
A wide variety of methods have been shown to be effective at blunting this hypertensive response. These include intravenous agents such as fentanyl, sufentanil, clonidine, ketamine and magnesium sulphate, local anesthetic methods such as injection at pin sites or full scalp blocks, deepening the volatile agent, oral premedication or a combination of these methods. There is no consensus on which of these methods is the best. Many anesthesiologists simply use boluses of propofol - a reliable way of accomplishing this effect with a familiar drug. It is also very common for anesthesiologists to use remifentanil, by increasing the infusion rate and or bolusing.
Remifentanil is an ultra-short acting opiate with such rapid onset and offset, that it is most easily and safely delivered by infusion. Increasingly in the literature, however, are reports of remifentanil administered as boluses rather than infusions. Boluses may be ideal for very short stimulating procedures such as intubation and skull pin fixation where a quick onset and offset are desired. Although the safety of bolusing remifentanil has been established in many studies , some authors are still apprehensive . Care must be taken to avoid bolusing with greater doses than required since this may lead to bradycardia and hypotension. In non-ventilated patients, respiratory depression is common and chest wall rigidity may occur at doses larger than 4ug/kg9.
Different bolus dose-effect studies have recommended the following for remifentanil in a variety of clinical settings:
- 3-5ug/kg with propofol 2mg/kg for intubation without muscle relaxants ,
- 2ug/kg with propofol TCI (>4ug/ml) and cisatracurium for intubation (no additional hemodynamic benefit using 4ug/kg)
- 1-1.25ug/kg for rapid sequence intubation with thiopentone 5-7mg/kg and succinylcholine 1mg/kg
- ED50 of 1.7ug/kg and ED95 of 2.88ug/kg for good to excellent intubating conditions in both infants and children (when used with 10ug/kg glycopyrrolate and 4mg/kg propofol)
- 3ug/kg (plus 4mg/kg propofol) provides similar intubating conditions when used in place of succinylcholine 2mg/kg for intubation in infants8
Remifentanil is not currently recommended for the following settings:
- As a sole agent for loss of consciousness with a high ED50 of 12ug/kg, lack of reliability and muscle rigidity common at such high doses
- Wide interindividual variability limit its use for labor analgesia (0.2-0.8ug/kg, median dose of 0.4ug/kg)
In neurosurgery, it is common to administer remifentanil as an infusion. Optimal infusion rates have already been investigated for intracranial surgery . However it is increasingly common to administer remifentanil as a bolus particularly during skull pin fixation, due to the desirable quick onset and offset, and there are no studies at present that have investigated optimal dose requirements for boluses in this setting.
At our institution we commonly administer remifentanil as a bolus during skull pin fixation and are interested in determining which bolus doses are safe and effective
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
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Ontario
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Toronto、Ontario、カナダ、M5T 2S8
- Toronto Western Hospital
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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:
Patients requiring skull pin fixation and general anesthesia for:
- Elective cervical spine surgery
- Elective craniotomies/brain tumor resection
- Elective transsphenoidal pituitary hypophysectomies
Exclusion Criteria:
Patients with evidence of raised intracranial pressure:
- GSC < 15
- Radiological evidence of significant rise in ICP (e.g. midline shift)
- Vascular anomalies in the brain
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:1.25 ug/kg normo-tensive 20-40 year olds
A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.
|
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
|
実験的:1.5 ug/kg normo-tensive 20-40 year olds
A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.
|
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
|
実験的:1.75 ug/kg normo-tensive 20-40 year olds
A single bolus dose of 1.75 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.
|
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
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実験的:1 ug/kg normo-tensive 65-75 year olds
A single bolus dose of 1 microgram per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old.
|
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
|
実験的:1.25 ug/kg normo-tensive 65-75 year olds
A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old.
|
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
|
実験的:1.5 ug/kg normo-tensive 65-75 year olds
1.5 ug/kg normo-tensive 65-75 year olds A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old. |
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
|
実験的:1 ug/kg hyper-tensive 65-75 year olds
A single bolus dose of 1 microgram per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.
|
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
|
実験的:1.25 ug/kg hyper-tensive 65-75 year olds
A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.
|
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
|
実験的:1.5 ug/kg hyper-tensive 65-75 year olds
A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.
|
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
|
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 |
時間枠 |
---|---|
To validate the safety and effectiveness of using remifentanil as a bolus for skull pin fixation
時間枠:10 minutes
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10 minutes
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二次結果の測定
結果測定 |
時間枠 |
---|---|
To determine the optimal doses for remifentanil in order to blunt the hemodynamic changes associated with skull pin fixation
時間枠:10 minutes
|
10 minutes
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to assess variability in dose requirements of remifentanil
時間枠:10 minutes
|
10 minutes
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to compare the dose effects in younger (20-40yo) vs. older (65-75yo) age groups
時間枠:10 minutes
|
10 minutes
|
to compare the dose effects in older (65-75yo) age groups in hypertensive versus non-hypertensive patients
時間枠:10 minutes
|
10 minutes
|
協力者と研究者
捜査官
- 主任研究者:Atul Prabhu, MD、University Health Network, Toronto
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 05-0684-B
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スカルピン挿入の臨床試験
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