Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Operative Cognitive Dysfunction After Breast Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774420
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Federico Linassi, University of Padova

Brief Summary:
Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values.

Condition or disease
Emergence Delirium Post-Operative Cognitive Dysfunction

Detailed Description:
Post-Operative Cognitive Dysfunction has not been yet investigated after general anaesthesia with Targeted-Controlled-Infusion (TCI) and Laryngeal-Mask-Airway (LMA), daily used in the investigator's Hospital to anesthetize women undergoing breast surgery. Aim of this trial is to define if neurocognitive tests (Montreal Cognitive Assessment, Trail Making Test A and B, Digit Span Test) before and after surgery relate to concentrations at effector's site (Ec) of propofol and remifentanil TCI and the values of Bispectral Index and Entropy monitoring and Surgical Plethysmographic Index (SPI).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Operative Cognitive Dysfunction After Breast Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI )in Women With Laryngeal Mask Airway
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021



Primary Outcome Measures :
  1. Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Montreal Cognitive Assessment test [ Time Frame: Patients will be subjected to Montreael Cognitive Assessment (MOCA) test one day before surgery and 1 day after surgery. This test has a score ranging from 1 (minimum) to 30 (maximum). Better neurocognitve outcome with higher scores) ]
    Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operative Montreal Cognitive Assessment test score and post-operative Montreal Cognitive Assessment test score

  2. Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Trail Making Test A and B [ Time Frame: Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required) ]
    Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Trail Making Test A and B test score and post-operative Trail Making Test A and B test score

  3. Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Digit Span Test [ Time Frame: Patients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scores ]
    Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Digit Span Test score and post-operative Digit Span Test test score

  4. Incidence of Post-Operative Delirium in breast-surgery patients [ Time Frame: Patients will be subjected to CAM-ICU 15 minutes after awakening from anaesthesia. This test can be positive (Delirium present) or negative (Delirium absent) ]
    Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM-ICU) test

  5. Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients [ Time Frame: Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery. Better neurocognitve outcome with lower scores ]
    Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Short Portable Mental Status Questionnaire score and post-operative Short Portable Mental Status Questionnaire test score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women subjected to breast surgery in general anaesthesia with Laryngeal-Mask-Airway (LMA) anesthetized with propofol and remifentanil delivered by Targeted-Controlled-Infusion (TCI) pumps. Women will be subjected to neurocognitive tests (MOCA, TMT A and B, DST) the day before surgery and on the first post-operative day. These test will be related to propofol and remifentanil concentrations at effector site during surgery and awakening, to BIS and Entropia values and to SPI value.
Criteria

Inclusion Criteria:

  • General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
  • Use of Laryngeal Mask airway

Exclusion Criteria:

  • Neurological pathologies
  • Haemodynamical instability during surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774420


Contacts
Layout table for location contacts
Contact: Federico Linassi, MD 049 8754256 federico.linassi@studenti.unipd.it

Locations
Layout table for location information
Italy
Treviso Regional Hospital Recruiting
Treviso, TV, Italy, 31100
Contact: Federico Linassi       linus889@icloud.com   
Sponsors and Collaborators
University of Padova
Investigators
Layout table for investigator information
Principal Investigator: Federico Linassi, MD University of Padova
Layout table for additonal information
Responsible Party: Federico Linassi, MD, Principal Investigator, University of Padova
ClinicalTrials.gov Identifier: NCT03774420    
Other Study ID Numbers: MAST
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federico Linassi, University of Padova:
Infusion pumps
Intraoperative brain monitoring
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Emergence Delirium
Cognitive Dysfunction
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Postoperative Complications
Pathologic Processes