Changes of Ciprofol Dosage and Bispectral Index Required for Loss of Consciousness in Patients of Different Ages: a Single-center, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Ciprofol dosage
研究概览
简要总结
This study aims to explore dose requirements for loss of consciousness and bispectral index changes during general anesthesia induction with ciprofol in patients of different ages, providing a reference for its rational clinical application.
详细描述
Ciprofol, a novel gamma-aminobutyric acid (GABA) receptor agonist, is structurally modified from propofol by adding a cyclopropyl group to its side chain, forming an R-type chiral structure. This modification enhances its affinity for GABA receptors, resulting in faster onset, rapid metabolism, higher potency, reduced injection pain, and milder respiratory/circulatory suppression. Ciprofol exhibits good safety and tolerability, smooth and rapid induction, complete recovery, and low incidence of injection pain, making it a promising alternative to propofol. Age is a critical factor influencing general anesthesia and anesthetic drug responses. Age-related changes in organ function affect pharmacokinetics and pharmacodynamics, leading to variations in required drug doses and characteristic electroencephalogram changes. Therefore, this study aims to compare ciprofol doses and BIS changes during general anesthesia induction across age groups, offering reference and guidance for clinical medication.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) The ASA classification I-II 2) BMI range: 18.5 < BMI ≤ 24.9 kg/m² 3) Scheduled for elective general anesthesia surgery 4) Signed informed consent by the patient or legal guardian
排除标准
- •1) Patients with central nervous system disorders or using medications affecting the central nervous system 2) Patients with cardiac, hepatic, pulmonary, or renal dysfunction 3) History of alcohol or drug abuse 4) Allergy to the study drug 5) Patients with hematologic or metabolic diseases 6) Participation in other drug clinical trials within the past 4 weeks 7) Refusal to participate in the study
结局指标
主要结局
Ciprofol dosage
时间窗: During anesthetic Induction
Ciprofol dose required to achieve loss of consciousness. Ciprofol was continuously infused via a micropump at a rate of 12 mg/kg/h. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and loss of eyelash reflex were used to assess sedation depth, with evaluations performed every 5 seconds. A MOAA/S score ≤1 and loss of eyelash reflex were defined as loss of consciousness (LOC).
Bispectral index
时间窗: Baseline (Before surgery)
Bispectral index before infusion, at loss of consciousness, and at 1 and 3 minutes post-loss.
次要结局
- heart rate (HR)(up to 3 minutes)
- SpO₂(up to 3 minutes)
- Mean arterial pressure (MAP)(up to 3 minutes)
- Incidence of adverse reactions including respiratory depression and injection pain(Baseline (Before surgery))