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临床试验/NCT03727464
NCT03727464已完成不适用

Memory Priming for Abstract and Concrete Words in General BIS Guided Propofol vs. Sevoflurane Anesthesia

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年1月7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
102
试验地点
1
主要终点
Implicit score

研究概览

简要总结

Memory priming under general anesthesia is a phenomenon of incredible interest in the study of consciousness and unconscious cognitive processing, and for clinical practice.

However results from anesthesiological literature are divergent and methodologies vary.

To overcome these limits, the present study aims at better defining the phenomenon of memory priming under general anesthesia, manipulating as experimental variables both the anesthetic drug used and the stimuli primed.

详细描述

Some patients may develop serious psychological sequelae after surgical intervention under general anesthesia due to implicit memory formation of intraoperative events.

A number of studies in the field of anesthesiology have tried to better define the phenomenon of implicit memory in general anesthesia, with conflicting results. While some studies demonstrated the existence of unconscious memory formation also under adequate general anesthesia (BIS ranging 40-60), others state that implicit memory formation is possible only during light sedation, and that, therefore, traumatic disorders due to unconscious intraoperative memories are imputable to inadequate anesthesiological intraoperative management. The methodologies used by these studies, however, are very heterogeneous, and often inaccurate from a cognitive point of view. Data from cognitive neuroscience, in fact, demonstrate that different linguistic material, e.g. abstract and concrete words, are processed and retrieved via different networks in the brain. Then, since different anesthetics are known to target different areas of the brain, it is assumable that implicit memory formation is influenced both by the specific drug used and by the type of stimuli primed.

Therefore in this experiment, the investigators aim at testing implicit memory for different word category, abstract vs. concrete words, in patients undergoing either propofol or sevoflurane general anesthesia. Also, a very strict methodology was used both for the construction of the stimuli and the stimulation and testing procedure, in order to maximize the priming effect and exclude the risk of false positive results. The investigators hypothesize that, considering the existing data on propofol and sevoflurane effects on the brain, and the known neural correlates for abstract and concrete word processing, the priming effect would be different for abstract and concrete words between patients under propofol or sevoflurane anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient undergoing general anesthesia for back surgery
  • American Society of Anesthesiology (ASA) physical status classification I or II
  • Italian native speaker
  • right handed (assessed with the Edinburgh Handedness Inventory)
  • not to suffer from memory deficits, hearing impairment or any other medical/psychiatric condition that could affect the memory performance or hearing

排除标准

  • to develop a postoperative cognitive dysfunction or delirium or any other medical complication that could prevent the memory testing or that could affect memory performance

研究组 & 干预措施

Propofol Abstract Priming

Experimental

Patients undergoing propofol general anesthesia and stimulation with a list of abstract words

干预措施: Abstract priming (Behavioral)

Propofol Abstract Priming

Experimental

Patients undergoing propofol general anesthesia and stimulation with a list of abstract words

干预措施: Propofol (Drug)

Propofol Concrete Priming

Experimental

Patients undergoing propofol general anesthesia and stimulation with a list of concrete words

干预措施: Concrete priming (Behavioral)

Propofol Concrete Priming

Experimental

Patients undergoing propofol general anesthesia and stimulation with a list of concrete words

干预措施: Propofol (Drug)

Propofol Controls

Active Comparator

Patients undergoing propofol anesthesia without any intraoperative priming

干预措施: Controls (Behavioral)

Propofol Controls

Active Comparator

Patients undergoing propofol anesthesia without any intraoperative priming

干预措施: Propofol (Drug)

Sevoflurane Abstract Priming

Experimental

Patients undergoing sevoflurane general anesthesia and stimulation with a list of abstract words

干预措施: Abstract priming (Behavioral)

Sevoflurane Abstract Priming

Experimental

Patients undergoing sevoflurane general anesthesia and stimulation with a list of abstract words

干预措施: Sevoflurane (Drug)

Sevoflurane Concrete Priming

Experimental

Patients undergoing sevoflurane general anesthesia and stimulation with a list of concrete words

干预措施: Concrete priming (Behavioral)

Sevoflurane Concrete Priming

Experimental

Patients undergoing sevoflurane general anesthesia and stimulation with a list of concrete words

干预措施: Sevoflurane (Drug)

Sevoflurane Controls

Active Comparator

Patients undergoing sevoflurane general anesthesia without any intraoperative priming

干预措施: Controls (Behavioral)

Sevoflurane Controls

Active Comparator

Patients undergoing sevoflurane general anesthesia without any intraoperative priming

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Implicit score

时间窗: 24 hours

Implicit memory is tested through a word stem completion test, in which the participant has to complete a three-letter stem with the first word that comes to mind. The completion test comprises both target stems (stems of word primed intra-operatively) and foils. The number of correct completions of target stems and foils is recorded as target and non target hits. The implicit score is then calculated as (target hits - nontarget hits)/total target stimuli. The score can therefore range (absolute values) from -1 to +1, where a positive score indicates memory priming.

次要结局

  • Target hits(24 hours)
  • Nontarget hits(24 hours)
  • Explicit recall of intraoperative words(before discharge from the Recovery Room and at 24 hours)
  • Explicit recall of intraoperative events(before discharge from the Recovery Room and at 24 hours)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleonora Orena

PhD

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

研究点 (1)

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