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Memory Priming in General Anesthesia

Primary Purpose

Unconscious (Psychology)

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Abstract priming
Concrete priming
Controls
Propofol
Sevoflurane
Sponsored by
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Unconscious (Psychology) focused on measuring Memory priming, Anesthesia, Language processing, Abstract and Concrete words, Neural correlates

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Arm Label

Propofol Abstract Priming

Propofol Concrete Priming

Propofol Controls

Sevoflurane Abstract Priming

Sevoflurane Concrete Priming

Sevoflurane Controls

Arm Description

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

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

Patients undergoing propofol anesthesia without any intraoperative priming

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

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

Patients undergoing sevoflurane general anesthesia without any intraoperative priming

Outcomes

Primary Outcome Measures

Implicit score
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.

Secondary Outcome Measures

Explicit recall of intraoperative words
The number of intraoperative primed words that the patient is able to recall without any cue
Explicit recall of intraoperative events
The explicit recall of intraoperative events assessed with the Brice Interview
Target hits
The number of correct stem completions (hits) with target words (i.e. words heard intraoperatively)
Nontarget hits
The number of correct stem completions (hits) with nontarget words (i.e. words not heard intraoperatively)

Full Information

First Posted
October 30, 2018
Last Updated
September 4, 2019
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT03727464
Brief Title
Memory Priming in General Anesthesia
Official Title
Memory Priming for Abstract and Concrete Words in General BIS Guided Propofol vs. Sevoflurane Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 7, 2013 (Actual)
Primary Completion Date
September 15, 2016 (Actual)
Study Completion Date
September 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborators
University of Milano Bicocca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unconscious (Psychology)
Keywords
Memory priming, Anesthesia, Language processing, Abstract and Concrete words, Neural correlates

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol Abstract Priming
Arm Type
Experimental
Arm Description
Patients undergoing propofol general anesthesia and stimulation with a list of abstract words
Arm Title
Propofol Concrete Priming
Arm Type
Experimental
Arm Description
Patients undergoing propofol general anesthesia and stimulation with a list of concrete words
Arm Title
Propofol Controls
Arm Type
Active Comparator
Arm Description
Patients undergoing propofol anesthesia without any intraoperative priming
Arm Title
Sevoflurane Abstract Priming
Arm Type
Experimental
Arm Description
Patients undergoing sevoflurane general anesthesia and stimulation with a list of abstract words
Arm Title
Sevoflurane Concrete Priming
Arm Type
Experimental
Arm Description
Patients undergoing sevoflurane general anesthesia and stimulation with a list of concrete words
Arm Title
Sevoflurane Controls
Arm Type
Active Comparator
Arm Description
Patients undergoing sevoflurane general anesthesia without any intraoperative priming
Intervention Type
Behavioral
Intervention Name(s)
Abstract priming
Intervention Description
Patients were primed with a list of abstract during their general anesthesia
Intervention Type
Behavioral
Intervention Name(s)
Concrete priming
Intervention Description
Patients were primed with a list of concrete during their general anesthesia
Intervention Type
Behavioral
Intervention Name(s)
Controls
Intervention Description
Patients did not receive any specific stimulation with words during their general anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol general anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane general anesthesia
Primary Outcome Measure Information:
Title
Implicit score
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Explicit recall of intraoperative words
Description
The number of intraoperative primed words that the patient is able to recall without any cue
Time Frame
before discharge from the Recovery Room and at 24 hours
Title
Explicit recall of intraoperative events
Description
The explicit recall of intraoperative events assessed with the Brice Interview
Time Frame
before discharge from the Recovery Room and at 24 hours
Title
Target hits
Description
The number of correct stem completions (hits) with target words (i.e. words heard intraoperatively)
Time Frame
24 hours
Title
Nontarget hits
Description
The number of correct stem completions (hits) with nontarget words (i.e. words not heard intraoperatively)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleonora F Orena, PhD
Organizational Affiliation
Fondazione IRCCS Istituto Neurologico Carlo Besta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta
City
Milan
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33399379
Citation
Orena EF, Landucci F, Ayadi R, Caldiroli D, Papagno C. Propofol and sevoflurane affect intra-operative memory formation of words differently: A prospective cohort study. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S50-S57. doi: 10.1097/EJA.0000000000001417.
Results Reference
derived

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Memory Priming in General Anesthesia

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