EC50 of Ciprofol Combined With Remifentanil for Inhibiting Tracheal Responses in Patients Undergoing Gynecological Surgery: a Two-phase Up-and-down Sequential Allocation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
- The combined induction of intubation with propofol and remifentanil is widely used in clinical anesthesia, primarily through a single intravenous injection. Target-controlled infusion (TCI) technology, which combines pharmacology with clinical practice, offers a more stable and precise infusion mode;
- This project aims to explore the half-effective concentration (EC50) of propofol combined with remifentanil for inhibiting tracheal intubation stimulation through a sequential approach under the monitoring of qNOX pain index.
详细描述
Patients undergoing elective surgery, aged 19 to 55 years, with ASA I or II, were selected for a sequential trial in two stages:
- In the first stage, induction dose of ciprofol was fixed at 0.4 mg/kg, and the EC50 and EC95 (exploratory) of remifentanil were measured.
- In the second stage, the concentration of remifentanil was fixed, and the EC50 and EC95 (exploratory) of ciprofol were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method.
- Additionally, the effectiveness of the qNOX index in guiding tracheal intubation stimulation was evaluated by analyzing the receiver operating characteristic (ROC) curves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective surgery and require general anesthesia with single-lumen endotracheal intubation: ASA physical status I-II, aged between 18 and 55 years, with a body mass index (BMI) between 18.5 and 30 kg/m2
排除标准
- •1.Emergency surgery patients, children, pregnant women; 2.Patients with unstable vital signs: such as blood pressure, heart rate, and blood oxygen saturation exceeding the safe range; 3.Patients with craniocerebral trauma or central nervous system lesions; 4.Patients who are allergic to the studied anesthetic drugs, or have recently received other experimental drugs, major surgery, radiotherapy, or chemotherapy; 5.Patients who refuse to sign the informed consent form.
研究组 & 干预措施
Stage 1
In the first stage, Induction dose of ciprofol was fixed at 0.4 mg/kg, and the EC50 and EC95 of remifentanil were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method.
干预措施: Cipofol combined with remifentanil administered via target-controlled infusion (Drug)
Stage 2
In the second stage, the concentration of remifentanil was fixed, and the EC50 and EC95 of ciprofol were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method.
干预措施: Cipofol combined with remifentanil administered via target-controlled infusion (Drug)
结局指标
主要结局
Heart rate
时间窗: 1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
blood pressure
时间窗: 1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
blood pressure
时间窗: 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
Half-effective concentration
时间窗: Calculated using SPSS software based on the TCI target concentration set during anesthesia induction (the fixed value of the inducing dose does not change over time).
Heart rate
时间窗: 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
CCS score (intubation score)
时间窗: within 1 min while intubation (satisfactory intubation conditions simultaneously meet: visible laryngoscope exposure, no vocal cord movement, no coughing, relaxed jaw, no limb movement; otherwise, it is considered unsatisfactory intubation conditions)
次要结局
- BIS index(1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).)
- qNOX index(1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).)
- EMG index(1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).)
- BIS index(5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).)
- qNOX index(5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).)
- EMG index(5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).)
研究者
bo xu
Medical Doctor
Guangzhou General Hospital of Guangzhou Military Command