Ciprofol EC50 para induzir perda de consciência em pacientes idosos
Ciprofol EC50 para induzir perda de consciência em pacientes idosos: um estudo exploratório baseado no método Up-and-Down de Dixon
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Zhejiang
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Hangzhou, Zhejiang, China, 310022
- Jiangling Wang
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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 ;
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
Outros nomes:
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Experimental: 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.
Outros nomes:
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Experimental: 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.
Outros nomes:
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Experimental: 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.
Outros nomes:
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Experimental: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Ciprofol EC50 (mg/Kg) for loss of consciousness
Prazo: From loss of consciousness (LOC) to 10 minutes after trachea intubation.
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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.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Plasma concentration of ciprofol when LOC.
Prazo: From the start of induction to loss of consciousness, approximately 4 to 8 minutes after start of induction.
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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
Prazo: 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
Prazo: 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
Prazo: 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.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Ji Zhu, Dr., Zhejiang Cancer Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-2024-76（IIT）
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Plan can be shared when required.
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