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临床试验/NCT06134037
NCT06134037已完成不适用

Effects of Aminophylline Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Concentrations at Start and End of Burst Suppression Occurence and on BIS (Bispectral Index) During the Induction Phase of Total Intravenous Anaesthesia With TCI

University of Padova1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年11月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Correlation between Concentration at the effector site of Propofol after Aminophylline bolus during Burst Suppression occurence

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 effects in lightining the anesthestic plan during Propofol anaesthesia with an intravenous bolus of 4 mg/kg.

Authors aimed to compare its effect during accidental episodes of Burst Suppression during the induction phase of 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, and also to lightining the anestetic plan (increase in Bipectral Index - BIS- values).

Authors aimed to compare its effect during accidental Burst Suppression episodes during the induction of total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital, with Eleveld Pharmacokinetic/Pharmacodynamic-PK/PD model).

The timing and relative Concentration of Propofol (CeP) from the start to the end of Burst suppression episodes with or without aminophylline bolus deliveres as soon as detected 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 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Remifentanil (Minto model)
  • Burst Suppression accidental occurence during the induction phase of anesthesia.

排除标准

  • Neurological disease
  • Psychiatric disease
  • Hypothension during Burst Suppression episodes, other Burst suppression episodes during Anesthesia maintenance.

研究组 & 干预措施

Aminophylline

Patients who received Aminophylline bolus (4 mg/kg) at Burst Suppression occurence during induction of general anesthesia conducted with Eleveld TCI model

干预措施: Aminophylline (Drug)

结局指标

主要结局

Correlation between Concentration at the effector site of Propofol after Aminophylline bolus during Burst Suppression occurence

时间窗: Authors 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 of Propofol and timing of Burst Suppression duration during 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

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Linassi

MD

University of Padova

研究点 (1)

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