Preoperative Dexmedetomidine & EC50 of Propofol (PreopDXM)
Preoperative Dexmedetomidine Reduces the EC50 of Propofol for Successful i-gelTM Insertion Without Muscle Relaxants
調査の概要
状態
条件
詳細な説明
Propofol is a useful induction agent for LMA insertion without muscle relaxants because it profoundly inhibits pharyngeal and laryngeal reactivity. A previous report showed that the effect-site concentration of propofol for successful classic LMA insertion in 50% of adults (EC50) without muscle relaxants in healthy male patients was 8.72 (0.55) µg ml-1. The EC50 of propofol may be dependent on the type of LMA used. A previous study comparing the EC50 of the propofol concentration between classic and proseal LMA insertions demonstrated that the EC50 of propofol needed for proseal LMA insertion was 35% greater than that needed for classic LMA insertion. Unfortunately, no investigation has been performed to determine the EC50 of the propofol concentration required for i-gel insertion without muscle relaxants.
Dexmedetomidine (DEX), a selective alpha-2 agonist, has sympatholytic, sedative, and analgesic properties. Such beneficial characteristics make DEX a useful anaesthetic adjuvant for general anaesthesia. Many reports have revealed the beneficial effects of DEX in terms of reducing intraoperative anaesthetic requirements, postoperative analgesic demand, and increased haemodynamic responses to noxious stimuli such as endotracheal intubation. A previous investigation showed that preoperative clonidine, an alpha-2 agonist, decreased the EC50 required for LMA insertion.
We hypothesised that preoperative DEX administration can reduce the propofol concentration required for i-gel insertion. In this study, we compared the EC50 of propofol needed for successful i-gel insertion without muscle relaxants between DEX and placebo groups
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Seoul、大韓民国、110-799
- Seoul National University of 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:
- ASA physical status I-II patients who were 20-65 years old and scheduled for general anaesthesia for urologic surgery
Exclusion Criteria:
- Patients with an allergy to alpha-2 adrenergic agonists or propofol
- Patients who anticipated difficult airway (cervical spinal disease, Mallampati score of III or IV, a mouth opening of <2.5 cm, and/or body mass index of >30 kg m-2), unstable teeth
- Patients with bradycardia of <50 beats/min, heart block greater than first degree, severe cardiorespiratory dysfunction
- Patients with symptoms of upper respiratory infection
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：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：トリプル
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：Group D : Dexmedetomidine + propofol group
In Group D, DEX (1 µg kg-1) was intravenously loaded for 10 min before induction of anaesthesia.
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All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of dexmedetomidine. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group D received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment. |
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プラセボコンパレーター：Group C : Saline + propofol group
In Group C, 0.9% of normal saline (1 µg kg-1) was loaded 10 min before induction of anaeshtesia.
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All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of normal saline. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group C received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min. After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment |
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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EC50 of propofol required for successful i-gel insertion
時間枠：During i-gel insertion anticipated up to 1 min
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The EC50 of propofol for successful i-gel insertion was determined by a modification of Dixon's up-and-down method.
The response of each patient determined the effect-site propofol concentration for the next patient.
If the response was deemed 'successful', the next target concentration of propofol was decreased by 0.5 µg mL-1.
If the response was deemed a 'failure', the target concentration was increased by the same dose.
The process was repeated until the sixth crossover point (success/failure) was obtained.
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During i-gel insertion anticipated up to 1 min
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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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the total dose of propofol infused before i-gel insertion
時間枠：During i-gel insertion time anticipated upto 1min
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The total amount of propofol infused before i-gel insertion was noted.
The insertion time, defined as the time from picking up the i-gel until the initiation of mechanical ventilation.
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During i-gel insertion time anticipated upto 1min
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the presence/severity of airway trauma after i-gel insertion
時間枠：At the time point of removing the i-gel from patient's mouth
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After removing the i-gel, airway trauma (defined as any blood staining on the device) was recorded.
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At the time point of removing the i-gel from patient's mouth
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協力者と研究者
捜査官
- スタディディレクター：Hee Pyung Park, MD PhD、Professor
- 主任研究者：Young Cheol Kim, Md PhD、Professor
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 (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
追加の関連 MeSH 用語
その他の研究ID番号
- PreopDXM_PPF
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