The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial
調査の概要
詳細な説明
This is a prospective, single-blind (participant and outcomes assessor-blinded), biased-coin design up-and-down sequential allocation trial. A total of 180 pediatric patients (ASA I-II) scheduled for elective surgery requiring LMA insertion will be enrolled and divided into three age groups: toddlers (1-3 years), preschoolers (4-6 years), and school-age children (7-12 years), with 60 patients per group.
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute. The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg. The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053. If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.
The study employs a single-blind design: the anesthesiologist who administers the study drug is aware of the ciprofol dose, whereas the anesthesiologist who performs the LMA insertion and the observer who evaluates the patient's response are both blinded to the dose assignment. LMA insertion will be attempted 90 seconds after drug administration. Successful insertion is defined as the absence of jaw tightness, gross purposeful movement, coughing, gagging, or laryngospasm during LMA insertion and cuff inflation. The primary outcome is the ED95 of ciprofol for successful LMA insertion in each age group, estimated using isotonic regression with bootstrap resampling.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Li Xu
- 電話番号：+862783663173
- メール：li_xu717@hust.edu.cn
研究場所
-
-
Hubei
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Wuhan、Hubei、中国、430030
- 募集
- Tongji Hospital
-
コンタクト：
- Li Xu
- メール：li_xu717@hust.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I or II
- Aged 1 to 12 years
- Scheduled for elective surgery requiring general anesthesia with laryngeal mask airway (LMA) insertion (e.g., ophthalmic surgery, skin lesion excision, minor abdominal or urological procedures, with expected surgical duration ≤ 2 hours)
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Known allergy or hypersensitivity to ciprofol, fentanyl, or any study-related drugs
- Intellectual disability, cognitive-affective disorders, psychiatric or neurological diseases
- Inability to cooperate with peripheral intravenous cannulation
- History of reactive airway disease or suspected difficult airway
- Body mass index (BMI) ≥ 30 kg/m² or ≤ 15 kg/m²
- History of sedative medication use
- Inability to understand the study protocol or participation in another clinical trial within the past 30 days
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：非ランダム化
- 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 |
|---|---|
|
実験的：Toddlers (1-3 years)
|
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute.
The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg.
The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053.
If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol
|
|
実験的：Preschoolers (4-6 years)
|
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute.
The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg.
The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053.
If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol
|
|
実験的：School-age (7-12 years)
|
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol, administered intravenously over 1 minute.
The initial ciprofol dose is set at 0.35 mg/kg, with a dose step size of 0.1 mg/kg.
The dose for each subsequent patient is determined by the biased-coin design: if the previous patient achieves successful LMA insertion (no movement), the next patient receives the same dose with a probability of 0.947 or a 0.1 mg/kg lower dose with a probability of 0.053.
If the previous patient fails (movement occurs), the next patient receives a 0.1 mg/kg higher dose.
All patients will receive a fixed dose of fentanyl (1 μg/kg) and a predetermined bolus dose of ciprofol
|
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 |
|---|---|---|
|
ED95 of ciprofol for LMA insertion in children
時間枠：At LMA insertion, 90 seconds after drug injection
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The ED95 of ciprofol (combined with fentanyl 1 μg/kg) for successful LMA insertion, defined as absence of movement, coughing, gagging, or laryngospasm during insertion and cuff inflation.
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At LMA insertion, 90 seconds after drug injection
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of adverse events within 5 minutes
時間枠：Within 5 minutes after drug injection
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Within 5 minutes after drug injection
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mean arterial pressure (MAP)
時間枠：from before induction to 1 minute afte LMA insertion
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blood pressure were documented at the following time points: T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
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from before induction to 1 minute afte LMA insertion
|
|
heart rate
時間枠：from before induction to 1 minute afte LMA insertion
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T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
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from before induction to 1 minute afte LMA insertion
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Bispectral Index (BIS)
時間枠：From before induction to 1 minute afte LMA insertion
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BIS values were documented at the following time points: T1 (before induction), T2 (at LMA insertion), and T3 (1 minute after LMA insertion)
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From before induction to 1 minute afte LMA insertion
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Pediatric Anesthesia Emergence Delirium (PAED) scale score
時間枠：Within 15-30 minutes in PACU
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Within 15-30 minutes in PACU
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
- TJ-IRB202606058
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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Ciprofolの臨床試験
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