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RecruitingNCT06497855Updated Jun 8, 2026

Impact of Estimated Concentration of Propofol on Implicit Memory Formation

An observational study in General Anaesthesia and Implicit Memory, sponsored by University of Padova. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by University of Padova · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 90 Years
Sex
Female
01

Study summary

Implicit memory formation and learning during general anaesthesia is a still debated question and no anesthetic regimen (ie intravenous anaesthesia vs inhalatory one) nor analgesic regimen (i.e. low or high opioids usage) has been identified for prevention.

With this study the investigators aim to investigate if, during Total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) different concentrations of Propofol at loss of responsiveness, maintenance and return of responsiveness can have a role in implicit memory formation.

Read the detailed description

Implicit memory formation and learning during general anaesthesia is a still debated question and no anesthetic regimen (ie intravenous anaesthesia vs inhalatory one) nor analgesic regimen (i.e. low or high opioids usage) has been identified for prevention.

With this study the investigators aim to investigate if, during Total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) different concentrations of Propofol at loss of responsiveness (CeP RoR), maintenance (CePMA) and return of responSiveness (CeP RoR) can have a role in implicit memory formation.

20 most common italiaN words will be continuously presented to the anaesthetized patients from Loss of responsiveness to end of surgery.

CeP RoR, MA and LoR, as well as patient state index (PSi) from Sedline monitor for hypnosis level monitoring will be recorded.

Within 24 hours, a trained psychologist will be present the patients the Word Steam Recognition Test, Free Recall and Force Choice recognition task to asses the presence of implicit memory formation. A second group, who did not hear the words, will be investigated to assess the role of chance in the above-mentioned test.

02

Conditions studied

  • General Anaesthesia
  • Implicit Memory
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Breast-Surgery women undergoing TIVA-TCI

Inclusion criteria

  • General anaesthesia with TIVA-TCI

Exclusion criteria

Exclusion Criteria:

  • ASA > III
  • Benzodiazepines premedication
  • Neurological/Psychiatric disease
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

    Patients who, during general anaesthesia, will hear the 20 words and will be tested form implicit memory formation.

  • Controls

    Patients who, during general anaesthesia, will not hear the 20 words and will be tested form implicit memory formation to assess the role of chance on the tests adopted

05

What researchers measure

Primary outcomes

  1. The role of Propofol Concentration at the loss of responsiveness on Implicit Memory formation

    CeP at LOR will be compared between patients who exhibit or not implicit memory formation.

    Time frame: CeP will be recorded at Loss of responsiveness. Word Steam recognition, Free recall and Forced Choice Recognition Task will be performed within 12-24 hours after surgery. These 3 tests are analysed togheter to check for implicit memory formation.

  2. The role of Propofol Concentration at the maintenance of anaesthesia on Implicit Memory formation

    CeP at anaesthesia maintenance will be compared between patients who exhibit or not implicit memory formation.

    Time frame: CeP will be recorded during anaesthesia maintenance. Word Steam recognition, Free recall and Forced Choice Recognition Task will be performed within 12-24 hours after surgery. These 3 tests are analysed togheter to check for implicit memory formation.

  3. The role of Propofol Concentration at the return of responsiveness on Implicit Memory formation

    CeP at ROR will be compared between patients who exhibit or not implicit memory formation.

    Time frame: CeP will be recorded at Return of responsiveness. Word Steam recognition, Free recall and Forced Choice Recognition Task will be performed within 12-24 hours after surgery. These 3 tests are analysed togheter to check for implicit memory formation.

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT06497855
Lead sponsor
University of Padova
Responsible party
Federico Linassi (PhD, University of Padova) — Principal investigator
First posted
Jul 12, 2024
Start date
Jul 1, 2024
Primary completion
Oct 31, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Jun 8, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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