Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil
Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil
Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on the determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators have demonstrated a significant and clinically relevant increase in CO and cerebral tissue oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more usual clinical practice of administrating classical vasoactive medication such as phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and SctO2. In previous research the investigators used standardized target controlled propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known that remifentanil has more intense haemodynamic side-effects compared to other opiates such as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid during anaesthesia of propofol combined with other opiates such as sufentanil.
Patients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep general anaesthesia, which is usually performed with the combination of drugs as mentioned above. Because these patients often experience severe haemodynamic fluctuations they need to be closely monitored.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Groningen、オランダ、9713GZ
- 募集
- University Medical Center Groningen
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コンタクト:
- rob spanjersberg
- メール:r.spanjersberg@umcg.nl
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主任研究者:
- Alain F Kalmar, MD, PhD
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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:
- Age: 18 years and older.
- Elective CABG surgery performed off-pump.
- Written informed consent to participate in this study.
- Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.
Exclusion Criteria:
- Refusal to participate in this study.
- Age: younger than 18 years.
- Pregnant.
- BMI > 35 kg/m2.
- Patients in which atropine is contra-indicated.
- Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.
- Urgent or emergency surgery.
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:単一グループの割り当て
- 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 |
|---|---|
|
アクティブコンパレータ:Remifentanil
Anaesthesia with remifentanil/propofol
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Anaesthesia with remifentanil/propofol.
|
|
アクティブコンパレータ:Sufentanil
Anaesthesia with sufentanil/propofol
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Anaesthesia with sufentanil/propofol
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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 |
時間枠 |
|---|---|
|
CO
時間枠:During anaesthesia
|
During anaesthesia
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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 |
|---|---|---|
|
MAP
時間枠:During anaesthesia
|
During anaesthesia
|
|
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Tissue oxygen saturation
時間枠:During anaesthesia
|
During anaesthesia
|
|
|
CO
時間枠:During anaesthesia
|
CO obtained by different devices/methods (i.e. the Vigileo device and TEE)
|
During anaesthesia
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協力者と研究者
捜査官
- 主任研究者:Alain F Kalmar, MD, PhD、University Medical Center Groningen
出版物と役立つリンク
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 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。