Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Hemodynamic changes: Heart rate （HR ）
研究概览
简要总结
To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.
详细描述
90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 ~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status Ⅰ-Ⅲ
- •Age over 65 years;
- •Body mass index (BMI) 20 ~ 30 kg/m2 ;
- •Elective noncardiac surgery;
排除标准
- •The patient or his/her family refused to participate in the clinical trial;
- •Severe heart, lung, liver or kidney dysfunction;
- •Expected difficult airway, requiring awake tracheal intubation;
- •Those who are allergic to the drugs used in this study;
- •Unsuccessful tracheal intubation twice;
- •Patients with mental illness or impaired consciousness;
研究组 & 干预措施
propofol group
According to grouping，patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil.
干预措施: Propofol (Drug)
ciprofol group
According to grouping，patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups.
干预措施: Ciprofol (Drug)
结局指标
主要结局
Hemodynamic changes: Heart rate （HR ）
时间窗: From the beginning of drug administration to 30 minutes after intubation
Heart rate （HR ）during anesthesia induction
Hemodynamic changes: Diastolic blood pressure(DBP)
时间窗: From the beginning of drug administration to 30 minutes after intubation
Diastolic blood pressure(DBP) during anesthesia induction
Hemodynamic changes：Systolic blood pressure (SBP)
时间窗: From the beginning of drug administration to 30 minutes after intubation
Systolic blood pressure (SBP) during anesthesia induction
次要结局
- adverse reactions: muscle fasciculation(anesthesia induction)
- perioperative hepatic function: Aspartate Aminotransferase ( AST)(Before surgery , 1day after operation)
- adverse reactions：arrhythmia(anesthesia induction)
- perioperative hepatic function: Alanine Aminotransferase ( ALT)(Before surgery , 1day after operation)
- perioperative renal function:Blood Urea Nitrogen(Before surgery , 1day after operation)
- adverse reactions: injection pain(anesthesia induction)
- perioperative renal function: creatine(Before surgery , 1day after operation)
- Monitoring Depth of Anesthesia(anesthesia induction)
研究者
Xiumei Song
Associate chief physician
Qianfoshan Hospital