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临床试验/NCT04129112
NCT04129112已完成不适用

Evaluation of Influencing Variables in Awakening Concentration and Concentration at Body Movements of Propofol TCI (Targeted Controlled Infusion) Targeted at the Effector Site

University of Padova1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年7月1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
75
试验地点
1
主要终点
Incidence of body movements in patients undergoing surgery without curare agents

研究概览

简要总结

Age has been related to awakening propofol concentration at effector site of TCI, but not to the loss of consciousness concentration, neither to the concentration of body movements during surgery, that can be interpreted as a sign of light anesthesia and lead to awareness.

This study aims to determinate the incidence and the propofol TCI concentration at the effector site, in patients undergoing general anaesthesia without NBDs, of any patients body movements, defined as any spontaneous movements (but no reflex movements) during surgery.

详细描述

Target-Controlled-Infusion (TCI), estimating the effect-size concentration (Ce) of propofol and its elimination time with a computerized system, provides the anaesthesiologist useful information to guide anaesthesia.

Although the correlation between propofol at the effector site at loss of consciousness (Ce LOC) and age is still debated with contrasting results, the correlation between propofol at the effector site at return of consciousness (Ce ROC) and age is well established, and some authors suggested that, due also for age-related changes in both pharmacokinetics and pharmacodynamics of propofol, its dosage should be reduced in elderly patients.

Lowering propofol dosage however, can lead to an higher incidence of awareness during general anaesthesia, even if anaesthesia management is guided by consciousness monitors.

Awareness during anaesthesia has recently been defined not as a binary phenomenon, but as a graded spectra of states and, during general anaesthesia without using neuromuscular blocking drugs (NBDs), body movement on the operating table can be taken as an indication of increasing probability of consciousness or 'light' anaesthesia.

Hence, this study aims to evaluate the impact of age on the concentration at the effector site of propofol-remifentanil anaesthesia administered with TCI pump and without NBDs. Concnetration at the effector site of Propofol at the return of consciousness (CeP ROC) and at any clinical sign of superficialization such as body movements (CeP BM) will be considered.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing general anesthesia with propofol and remifentanil delivered with TCI infusion pump

排除标准

  • neurological or psychiatric or cerebrovascular diseases
  • renal insufficiency
  • patients unable to understand the information contained in the informed consent form,
  • patients with intraoperative hemodynamic instability or
  • patients who was delivered curare agents during anaesthesia

研究组 & 干预措施

Patients with body movements

Patient who, under general anesthesia without curare agents, during surgery has any body movements that are no reflexes movements

干预措施: We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening (Drug)

Patients without body movements

Patient who, under general anesthesia without curare agents, during surgery has no body movements

干预措施: We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening (Drug)

结局指标

主要结局

Incidence of body movements in patients undergoing surgery without curare agents

时间窗: During surgery

We will note if patients have spontaneous movements during surgery, and calculate the incidence of the phenomenon.

次要结局

  • Concentration of propofol at body movements(Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery)
  • Concentration of propofol at return of consciousness(Patients will be subjected to Sort Portable Mental Status Questionnaire (SPMSQ) before surgery. Other variables are collected during surgery)

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, Principal investigator

University of Padova

研究点 (1)

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