The Effective Blood Concentration of Ciprofol

Официальное название

Median Effective Concentration of Ciprofol and Its Correlation With Bispectral Index: A Prospective Observational Study

Обзор

1. Eligible patients were selected and enrolled in the study. 2. General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction. 3. The patients' pain and cognition are followed up after surgery.

Вмешательства

• Препарат Ciprofol
  Beginning with an initial target plasma concentration of ciprofol at 1.2 μg/mL. Assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and Bispectral Index (BIS) values are performed every minute until the patient achieves a complete anesthetic state (defined as an MOAA/S score of 0).

Первичные конечные точки

• The effect-site concentration of cipofol, when MOAAS reaches 2 [Срок оценки: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).]

Вторичные конечные точки (5)

• The effect-site concentration of cipofol, when MOAA/S reaches 0. [Срок оценки: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).]
• Bispectral index [Срок оценки: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the BIS values.]
• The EC₅₀ and EC₉₅ of ciprofol [Срок оценки: From the beginning of anesthesia induction until 1 minute after intubation , the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).]
• Heart rate [Срок оценки: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the HR.]
• Blood pressure [Срок оценки: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the systolic blood pressure, diastolic blood pressure and mean arterial pressure.]

Критерии участия

Критерии включения

• Patients aged 18-65 years
• Scheduled for elective thyroidectomy
• ASA physical status classification I-II
• Willing to participate and providing written informed consent

Критерии исключения

• Recent use of sedatives or opioid analgesics
• Severe hepatic or renal dysfunction defined as:Child-Pugh class C (score ≥10), Creatinine clearance <35 mL/min ,Requiring preoperative dialysis
• Significant cardiovascular comorbidities
• Body mass index ≥35 kg/m² or <18.5 kg/m²
• Known hypersensitivity or adverse reactions to propofol/ciprofol
• Neuropsychiatric disorders including:Alzheimer's disease,History of cerebrovascular events,Traumatic brain injury,Space-occupying brain lesions,Other significant neurological deficits

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking University Shenzhen Hospital — Шэньчжэнь

Публикации

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• Gu Y, Hao J, Wang J, Liang P, Peng X, Qin X, Zhang Y, He D. Effectiveness Assessment of Bispectral Index Monitoring Compared with Conventional Monitoring in General Anesthesia: A Systematic Review and Meta-Analysis. Anesthesiol Res Pract. 2024 Aug 7;2024:5555481. doi: 10.1155/2024/5555481. eCollection 2024. PMID 39149130
• Chiang MH, Wu SC, Hsu SW, Chin JC. Bispectral Index and non-Bispectral Index anesthetic protocols on postoperative recovery outcomes. Minerva Anestesiol. 2018 Feb;84(2):216-228. doi: 10.23736/S0375-9393.17.12033-X. Epub 2017 Oct 12. PMID 29027770

Идентификаторы

NCT: NCT07294989 · 2025-117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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