Emergence DeliriumNCT03774420
Post Operative Cognitive Dysfunction After Oncologic Surgery
An observational study of Emergence Delirium and Post-Operative Cognitive Dysfunction, run by University of Padova at 1 site in Italy.
Trial summary
Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, and Postoperative Delirium, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergence Delirium, Post-Operative Cognitive Dysfunction
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2019to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women and Men subjected to oncologic surgery (breast, urologic general surgery) in general anaesthesia with Laryngeal-Mask-Airway (LMA) anesthetized with propofol and remifentanil delivered by Targeted-Controlled-Infusion (TCI) pumps. Patients will be subjected to neurocognitive tests (MMSE, GEMS, TMT A and B) the day before surgery and before hospital discharge. 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 and pupillometry values.
Who may be able to join
- General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
- Use of Laryngeal Mask airway
Who cannot join
- Neurological pathologies
- Haemodynamical instability during surgery
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, linus889@icloud.com
About this study
Official title: Post-Operative Cognitive Dysfunction After Oncologic Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI ) in Surgical Patients With Laryngeal Mask Airway
Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, and Postoperative Delirium, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values as well as to Pupillometry values (in particular Pupil Diameter, Pupil Latency, and Maximum Contraction Velocity).
Read the 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 patients undergoing oncologic surgery (breast, urologic and general 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, and CAM for Postoperative Delirium relate to concentrations at effector's site (Ce) of propofol and remifentanil TCI and the values of Bispectral Index and Entropy monitoring and Surgical Plethysmographic Index (SPI), as well as to Pupillometry values.
- Keywords
- Infusion pumps, Intraoperative brain monitoring
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients detected with Global Examination of Mental Test (GEMS)
Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operative Global Examination of Mental Test (GEMS) test. Better neurocognitve outcome with higher scores)
Measured: Patients will be subjected to Global Examination of Mental Test (GEMS) test one day before surgery and 1 day after surgery.
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients detected with Minimental State Examination (MMSE)
Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operativeMinimental State Examination (MMSE) test. Better neurocognitve outcome with higher scores)
Measured: Patients will be subjected to Minimental State Examination (MMSE) test one day before surgery and 1 day after surgery.
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients detected with Trail Making Test A and B
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. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required)
Measured: Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery.
Incidence of Post-Operative Delirium in oncologic surgery (breast, urolgic and general surgery) patients
Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM) test. Worse neurocognitve outcome with higher scores (ranging from 0 to 4)
Measured: Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia .
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients
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. Better neurocognitve outcome with higher scores (ranging 0 to 10)
Measured: Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery.
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients detected with Confusion Assessment Method (CAM)
Discover Post-Operative Cognitive Dysfunction analyzing changes with Confusion Assessment method (CAM). Worse neurocongitive outcome with lower scores.
Measured: Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia.
Incidence of Emergence Delirium in oncologic surgery (breast, urolgic and general surgery) patients detected with 4AT test
Discover Post-Operative Cognitive Dysfunction analyzing acute changes in postoperative congition function utilizing the 4AT test. Worse neurocognitve outcome with higher scores. Worse neurocognitve outcome with higher scores
Measured: Patients will be subjected to 4 AT test within 1 day from awakening from anesthesia .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start3 Jul 2019
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies 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
- 200 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
- Investigators
- Federico Linassi, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774420
- Sponsor's protocol ID
- MAST
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2018
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Cognitive Dysfunction After Oncologic Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI ) in Surgical Patients With Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT03774420
- Acronym / sponsor ID
- MAST
- Keywords
- Infusion pumps, Intraoperative brain monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Dec 2018 (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.
Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, and Postoperative Delirium, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values as well as to Pupillometry values (in particular Pupil Diameter, Pupil Latency, and Maximum Contraction Velocity).
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 patients undergoing oncologic surgery (breast, urologic and general 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, and CAM for Postoperative Delirium relate to concentrations at effector's site (Ce) of propofol and remifentanil TCI and the values of Bispectral Index and Entropy monitoring and Surgical Plethysmographic Index (SPI), as well as to Pupillometry values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women and Men subjected to oncologic surgery (breast, urologic general surgery) in general anaesthesia with Laryngeal-Mask-Airway (LMA) anesthetized with propofol and remifentanil delivered by Targeted-Controlled-Infusion (TCI) pumps. Patients will be subjected to neurocognitive tests (MMSE, GEMS, TMT A and B) the day before surgery and before hospital discharge. 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 and pupillometry values.
Key inclusion criteria (2 listed)
- General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
- Use of Laryngeal Mask airway
Key exclusion criteria (2 listed)
- Neurological pathologies
- Haemodynamical instability during surgery
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
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients detected with Global Examination of Mental Test (GEMS)
Time frame: Patients will be subjected to Global Examination of Mental Test (GEMS) test one day before surgery and 1 day after surgery.
Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operative Global Examination of Mental Test (GEMS) test. Better neurocognitve outcome with higher scores)
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients detected with Minimental State Examination (MMSE)
Time frame: Patients will be subjected to Minimental State Examination (MMSE) test one day before surgery and 1 day after surgery.
Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operativeMinimental State Examination (MMSE) test. Better neurocognitve outcome with higher scores)
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general 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.
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. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required)
Incidence of Post-Operative Delirium in oncologic surgery (breast, urolgic and general surgery) patients
Time frame: Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia .
Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM) test. Worse neurocognitve outcome with higher scores (ranging from 0 to 4)
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients
Time frame: Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery.
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. Better neurocognitve outcome with higher scores (ranging 0 to 10)
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients detected with Confusion Assessment Method (CAM)
Time frame: Patients will be subjected to Confusion Assessment Method (CAM) within 1 hour from awakening from anesthesia.
Discover Post-Operative Cognitive Dysfunction analyzing changes with Confusion Assessment method (CAM). Worse neurocongitive outcome with lower scores.
Incidence of Emergence Delirium in oncologic surgery (breast, urolgic and general surgery) patients detected with 4AT test
Time frame: Patients will be subjected to 4 AT test within 1 day from awakening from anesthesia .
Discover Post-Operative Cognitive Dysfunction analyzing acute changes in postoperative congition function utilizing the 4AT test. Worse neurocognitve outcome with higher scores. Worse neurocognitve outcome with higher scores
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 16 Oct 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.
Federico Linassi, MD principal investigator
University of Padova
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 Emergence Delirium and Post-Operative Cognitive Dysfunction, 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 2 inclusion and 2 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 16 Oct 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?
Contact Federico Linassi, MD (049 8754256, federico.linassi@studenti.unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-Operative Cognitive Dysfunction in oncologic surgery (breast, urolgic and general surgery) patients detected with Global Examination of Mental Test (GEMS) (time frame: Patients will be subjected to Global Examination of Mental Test (GEMS) test one day before surgery and 1 day after surgery.). The study lists 7 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 16 Oct 2026.