NCT03727464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

3.7 years

First QC Date

October 30, 2018

Last Update Submit

September 4, 2019

Conditions

Keywords

Memory primingAnesthesiaLanguage processingAbstract and Concrete wordsNeural correlates

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Secondary Outcomes (4)

  • 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

  • Target hits

    24 hours

  • Nontarget hits

    24 hours

Study Arms (6)

Propofol Abstract Priming

EXPERIMENTAL

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

Behavioral: Abstract primingDrug: Propofol

Propofol Concrete Priming

EXPERIMENTAL

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

Behavioral: Concrete primingDrug: Propofol

Propofol Controls

ACTIVE COMPARATOR

Patients undergoing propofol anesthesia without any intraoperative priming

Behavioral: ControlsDrug: Propofol

Sevoflurane Abstract Priming

EXPERIMENTAL

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

Behavioral: Abstract primingDrug: Sevoflurane

Sevoflurane Concrete Priming

EXPERIMENTAL

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

Behavioral: Concrete primingDrug: Sevoflurane

Sevoflurane Controls

ACTIVE COMPARATOR

Patients undergoing sevoflurane general anesthesia without any intraoperative priming

Behavioral: ControlsDrug: Sevoflurane

Interventions

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

Propofol Abstract PrimingSevoflurane Abstract Priming

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

Propofol Concrete PrimingSevoflurane Concrete Priming
ControlsBEHAVIORAL

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

Propofol ControlsSevoflurane Controls

Propofol general anesthesia

Propofol Abstract PrimingPropofol Concrete PrimingPropofol Controls

Sevoflurane general anesthesia

Sevoflurane Abstract PrimingSevoflurane Concrete PrimingSevoflurane Controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Unconsciousness

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Consciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Eleonora F Orena, PhD

    Fondazione IRCCS Istituto Neurologico Carlo Besta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 1, 2018

Study Start

January 7, 2013

Primary Completion

September 15, 2016

Study Completion

September 15, 2016

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations