Median Effective Concentration of Ciprofol and Its Correlation With Bispectral Index: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- The effect-site concentration of cipofol, when MOAAS reaches 2
研究概览
简要总结
- Eligible patients were selected and enrolled in the study.
- General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction.
- The patients' pain and cognition are followed up after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years
- •Scheduled for elective thyroidectomy
- •ASA physical status classification I-II
- •Willing to participate and providing written informed consent
排除标准
- •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
研究组 & 干预措施
ciprofol group
Anesthesia induction was achieved through target-controlled infusion of ciprofol.
干预措施: Ciprofol (Drug)
结局指标
主要结局
The effect-site concentration of cipofol, when MOAAS reaches 2
时间窗: 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).
The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 2. (Modified Observer's Assessment of Alertness/Sedation: 5--Responds readily to name spoken in normal tone ； 4--Lethargic response to name spoken in normal tone ； 3--Responds only after name is called loudly and/or repeatedly ； 2--Responds only after mild prodding or shaking ； 1--Responds only after painful trapezius squeeze ； 0--No response after painful trapezius squeeze；)
次要结局
- The effect-site concentration of cipofol, when MOAA/S reaches 0.(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(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(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(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(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.)