Impact of Estimated Concentration of Propofol on Implicit Memory Formation

NCT ID: NCT06497855

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-11-15

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• General anaesthesia with TIVA-TCI

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ImpliMAST

Identifier Type: -

Identifier Source: org_study_id