Memory Priming in General Anesthesia

NCT ID: NCT03727464

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-07

Study Completion Date

2016-09-15

Brief Summary

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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

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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.

Conditions

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Unconscious (Psychology)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Propofol Abstract Priming

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

Group Type EXPERIMENTAL

Abstract priming

Intervention Type BEHAVIORAL

Patients were primed with a list of abstract during their general anesthesia

Propofol

Intervention Type DRUG

Propofol general anesthesia

Propofol Concrete Priming

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

Group Type EXPERIMENTAL

Concrete priming

Intervention Type BEHAVIORAL

Patients were primed with a list of concrete during their general anesthesia

Propofol

Intervention Type DRUG

Propofol general anesthesia

Propofol Controls

Patients undergoing propofol anesthesia without any intraoperative priming

Group Type ACTIVE_COMPARATOR

Controls

Intervention Type BEHAVIORAL

Patients did not receive any specific stimulation with words during their general anesthesia

Propofol

Intervention Type DRUG

Propofol general anesthesia

Sevoflurane Abstract Priming

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

Group Type EXPERIMENTAL

Abstract priming

Intervention Type BEHAVIORAL

Patients were primed with a list of abstract during their general anesthesia

Sevoflurane

Intervention Type DRUG

Sevoflurane general anesthesia

Sevoflurane Concrete Priming

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

Group Type EXPERIMENTAL

Concrete priming

Intervention Type BEHAVIORAL

Patients were primed with a list of concrete during their general anesthesia

Sevoflurane

Intervention Type DRUG

Sevoflurane general anesthesia

Sevoflurane Controls

Patients undergoing sevoflurane general anesthesia without any intraoperative priming

Group Type ACTIVE_COMPARATOR

Controls

Intervention Type BEHAVIORAL

Patients did not receive any specific stimulation with words during their general anesthesia

Sevoflurane

Intervention Type DRUG

Sevoflurane general anesthesia

Interventions

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Abstract priming

Patients were primed with a list of abstract during their general anesthesia

Intervention Type BEHAVIORAL

Concrete priming

Patients were primed with a list of concrete during their general anesthesia

Intervention Type BEHAVIORAL

Controls

Patients did not receive any specific stimulation with words during their general anesthesia

Intervention Type BEHAVIORAL

Propofol

Propofol general anesthesia

Intervention Type DRUG

Sevoflurane

Sevoflurane general anesthesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Eleonora Orena

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eleonora F Orena, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Neurologico Carlo Besta

Locations

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Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 33399379 (View on PubMed)

Other Identifiers

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AR-INNCB-PRIMING-2012

Identifier Type: -

Identifier Source: org_study_id

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