Impact of Estimated Concentration of Propofol on Implicit Memory Formation

NCT06497855 | Not Yet Recruiting DMC

• 1 other identifier: ImpliMAST
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

General Anaesthesia; Implicit Memory

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast-Surgery women undergoing TIVA-TCI

You may qualify if:

• General anaesthesia with TIVA-TCI

You may not qualify if:

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

Sponsors & Collaborators

• University of Padova: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 15, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-06