Effects of Aminophylline Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness and on BIS (Bispectral Index) After Total Intravenous Anaesthesia With TCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Correlation between Concentration at the effector site of Propofol after Aminophylline
研究概览
简要总结
Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.
We aimed to compare its effect during a total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital.
详细描述
Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.
We aimed to compare its effect during a total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital (with Eleveld or Schnider Pharmacokinetic/Pharmacodynamic-PK/PD model).
The timing from stop of propofol infusion to eye opening and return of responsiveness, the relative Concentration of Propofol (CeP) and the power spectrum of the Bispectral Index (BIS) with or without aminophylline bolus were taken into account.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)
排除标准
- •Neurological disease
- •Psychiatric disease
研究组 & 干预措施
Aminophylline
Patients who received Aminophylline bolus (4 mg/kg) at the end of general anesthesia conducted with Eleveld or Schnider TCI model (this model was chosen at anesthesiologist's discretion)
干预措施: Aminophyllin (Drug)
Not Aminophylline
Patients who did not received Aminophylline bolus (4 mg/kg) at the end of general anesthesia conducted with Eleveld or SchniderTCI model (this model was chosen at anesthesiologist's discretion
干预措施: Aminophyllin (Drug)
结局指标
主要结局
Correlation between Concentration at the effector site of Propofol after Aminophylline
时间窗: We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start of anaesthesia until the emergence from anesthesia
Discover if, after an aminophylline bolus, there are differences between Concentrations at the effector site and timing at eye opening of Propofol using the Eleveld TCI model or Schnider TCI model, after standard general anaesthesia conducted with Propofol and remifentanil delivered with target controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia
次要结局
未报告次要终点
研究者
Federico Linassi
MD, Principal investigator
University of Padova