Ciprofol EC50 per indurre la perdita di coscienza nei pazienti anziani
Ciprofol EC50 per indurre la perdita di coscienza nei pazienti anziani: uno studio esplorativo basato sul metodo Up-and-Down di 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Zhejiang
-
Hangzhou, Zhejiang, Cina, 310022
- Jiangling Wang
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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 ;
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Ciprofol EC50 (mg/Kg) for loss of consciousness
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Plasma concentration of ciprofol when LOC.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Ji Zhu, Dr., Zhejiang Cancer Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB-2024-76（IIT）
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Plan can be shared when required.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .