Ciprofol EC50 pro navození ztráty vědomí u starších pacientů
Ciprofol EC50 pro navození ztráty vědomí u starších pacientů: Průzkumná studie založená na Dixonově metodě nahoru a dolů
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
-
-
Zhejiang
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Hangzhou, Zhejiang, Čína, 310022
- Jiangling Wang
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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 ;
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
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Experimentální: 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.
Ostatní jména:
|
|
Experimentální: 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.
Ostatní jména:
|
|
Experimentální: 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.
Ostatní jména:
|
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Experimentální: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Ciprofol EC50 (mg/Kg) for loss of consciousness
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Plasma concentration of ciprofol when LOC.
Časové okno: 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.
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The mean artery pressure
Časové okno: From entering the OR to 10 minutes after trachea intubation.
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Hemodynamic fluctuation during induction |
From entering the OR to 10 minutes after trachea intubation.
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The heart rate
Časové okno: From entering the OR to 10 minutes after trachea intubation.
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Hemodynamic fluctuation during induction |
From entering the OR to 10 minutes after trachea intubation.
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Incidence of adverse events
Časové okno: From entering the OR to 10 minutes after trachea intubation.
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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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Ji Zhu, Dr., Zhejiang Cancer Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB-2024-76（IIT）
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Plan can be shared when required.
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