General AnaesthesiaNCT06497855
Impact of Estimated Concentration of Propofol on Implicit Memory Formation
An observational study of General Anaesthesia and Implicit Memory, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- General Anaesthesia, Implicit Memory
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Adult, Older adult
Study population: Breast-Surgery women undergoing TIVA-TCI
Who may be able to join
- General anaesthesia with TIVA-TCI
Who cannot join
- ASA > III
- Benzodiazepines premedication
- Neurological/Psychiatric disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Treviso Regional Hospital
Treviso, TV, 31100
Federico Linassi, 0422322440, linus889@icloud.com
Federico Linassi, linus889@icloud.com
About this study
Official title: Impact of Target Controlled Infusion Estimated Concentration of Propofol on Implicit Memory Formation During Propofol-Remifentanil General Anaesthesia
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.
- Conditions
- General Anaesthesia, Implicit Memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Linassi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497855
- Sponsor's protocol ID
- ImpliMAST
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Target Controlled Infusion Estimated Concentration of Propofol on Implicit Memory Formation During Propofol-Remifentanil General Anaesthesia
- ClinicalTrials.gov ID
- NCT06497855
- Acronym / sponsor ID
- ImpliMAST
- Conditions
- General Anaesthesia, Implicit Memory
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Breast-Surgery women undergoing TIVA-TCI
Key inclusion criteria (1 listed)
- General anaesthesia with TIVA-TCI
Key exclusion criteria (3 listed)
- ASA > III
- Benzodiazepines premedication
- Neurological/Psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The role of Propofol Concentration at the loss of responsiveness on 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.
CeP at LOR will be compared between patients who exhibit or not implicit memory formation.
The role of Propofol Concentration at the maintenance of anaesthesia on 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.
CeP at anaesthesia maintenance will be compared between patients who exhibit or not implicit memory formation.
The role of Propofol Concentration at the return of responsiveness on 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.
CeP at ROR will be compared between patients who exhibit or not implicit memory formation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anaesthesia and Implicit Memory, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of Propofol Concentration at the loss of responsiveness on 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.