高齢患者の意識喪失を誘発するためのシプロフォール EC50
高齢患者の意識喪失を誘発するシプロフォール EC50: Dixon の Up-and-Down 法に基づく探索的研究
ciprofol is a recently introduced novel sedative drug. In comparison to the traditional propofol, ciprofol exhibits a higher affinity for GABA A receptors, approximately 4-5 times that of propofol, and possesses fewer side effects, particularly notable in respiratory depression and injection pain. In the context of general anesthesia induction, recent research has confirmed a 100% success rate in the induction of general anesthesia for elderly patients (65-80 years old) undergoing non-cardiac surgery with a dosage range of 0.2mg/kg-0.4mg/kg ciprofol. However, for elderly patients aged 65 and above, even up to 85 years old, it is currently not entirely clear what dosage should be selected for patients in different age groups. Consequently, we have designed this trial with the aim of exploring the dosage requirements of ciprofol during general anesthesia induction among elderly patients in various age brackets.
Methods: This is a prospective, non-controlled, non-randomized, single-blind study. Elderly patients aged 65 years and older were enrolled in the study with American Society of Anesthesiologists (ASA) physical status I or II undergoing general anesthesia. All patients were divided into five groups according to age, and the corresponding initial dose of ciprofol administered was selected according to the grouping, with subsequent doses of ciprofol determined according to the Dixon up-and-down method. At least seven crossover points were obtained before the conclusion of the study.The primary outcomes were the dose of ciprofol administered at the time of loss of consciousness (mg/Kg) and the plasma concentration of ciprofol.
調査の概要
詳細な説明
After received the approvement of ethics committee of the Cancer Hospital of the University of Chinese Academy of Sciences (approval number IRB-2024-76(IIT)). The study was registered before patient enrollment in Clinicaltrials.Written informed consent was obtained from all participants. The study was performed from Jan 1, 2024 to Dec 31, 2025. 150 patients aged 65 years and above, ASA physical status I or II, undergoing surgery under general anesthesia and who were not allergic to the study drug were included in this study. Basic monitoring such as 3-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. All patients were divided into five groups according to age, The initial dose of ciprofol for the first elderly patient was 0.2-0.4 mg/kg, the initial concentration was 0.4 mg/Kg for patients aged 65-74 years, 0.3 mg/Kg for patients aged 75-84 years, and 0.2 mg/Kg for patients aged 85 years or older, and the ciprofol doses for adjacent patients were set to be equidistantly spaced up and down by 0.05 mg/kg. Evaluation of the eyelash reflex and speech reflex was performed after intravenous infusion of ciprofol to observe whether LOC occurred within 4 min. After loss of consciousness, sufentanil (5ug/ml, diluted in 0.9% saline) and rocuronium bromide were given for endotracheal intubation.
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
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310022
- Jiangling Wang
-
-
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:
- 65 ≤ age years;
- ASA physical state I and II;
- Hadn't a history of allergy to the drugs used in this study;
Exclusion Criteria:
- America Society of Anesthesiologists (ASA) class >III;
- Allergic to anesthetic solutions or the drugs used in this study;
- Body mass index (BMI) ≤ 20 or ≥ 30 kg/m2;
- Using hypnotics, opioid analgesics, or anti-anxiety medications;
- Known or suspected heart failure (ejection fraction <40%), severe respiratory disease, renal or metabolic disease
- Refuse to participate or participate with other clinical investigators ;
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：順次割り当て
- 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：65-69 years old
The initial dose of ciprofol was 0.4mg/ in this group. |
The initial dose of ciprofol was 0.4mg/Kg for induction in this group.
他の名前：
|
|
実験的：70-74 years old
The initial dose of ciprofol was 0.4mg/ in this group. |
The initial dose of ciprofol was 0.4mg/Kg for induction in this group.
他の名前：
|
|
実験的：75-79 years old
The initial dose of ciprofol was 0.3mg/ in this group. |
The initial dose of ciprofol was 0.3mg/Kg for induction in this group.
他の名前：
|
|
実験的：80-84 years old
The initial dose of ciprofol was 0.3mg/ in this group. |
The initial dose of ciprofol was 0.3mg/Kg for induction in this group.
他の名前：
|
|
実験的：Older than 85 years (include 85 years old)
The initial dose of ciprofol was 0.2mg/ in this group. |
The initial dose of ciprofol was 0.2mg/Kg for induction in this group.
他の名前：
|
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 |
|---|---|---|
|
Ciprofol EC50 (mg/Kg) for loss of consciousness
時間枠：From loss of consciousness (LOC) to 10 minutes after trachea intubation.
|
Use up-and-down method to evaluate the Ciprofol EC50 for loss of consciousness in different age groups. |
From loss of consciousness (LOC) to 10 minutes after trachea intubation.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plasma concentration of ciprofol when LOC.
時間枠：From the start of induction to loss of consciousness, approximately 4 to 8 minutes after start of induction.
|
Measure the plasma concentration of ciprofol when LOC. |
From the start of induction to loss of consciousness, approximately 4 to 8 minutes after start of induction.
|
|
The mean artery pressure
時間枠：From entering the OR to 10 minutes after trachea intubation.
|
Hemodynamic fluctuation during induction |
From entering the OR to 10 minutes after trachea intubation.
|
|
The heart rate
時間枠：From entering the OR to 10 minutes after trachea intubation.
|
Hemodynamic fluctuation during induction |
From entering the OR to 10 minutes after trachea intubation.
|
|
Incidence of adverse events
時間枠：From entering the OR to 10 minutes after trachea intubation.
|
Measuring and recording the adverse events such as hypotension, hypertension, bradycardia and tachycardia during induction period. |
From entering the OR to 10 minutes after trachea intubation.
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Ji Zhu, Dr.、Zhejiang Cancer Hospital
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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。