Emergence DeliriumNCT03950557
Post Operative Cognitive Dysfunction and Delirium After Spinal Surgery
An observational study of Emergence Delirium and Post-Operative Cognitive Dysfunction, run by University of Padova.
Trial summary
Aim of this trial is to define if Post-Operative Cognitive Dysfunction and Delirium, 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. 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
- No sites listed yet
- Study dates
- 1 Jul 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients subjected to spinal surgery in general anaesthesia 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, Pfeiffer, CAM) the day before surgery, 15 and 60 minutes after awakening (only CAM) 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 intraoperative blood pressure values.
Who may be able to join
- General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
- Surgical duration > 60 minutes
Who cannot join
- Neurological pathologies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post-Operative Cognitive Dysfunction and Delirium After Spinal Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data, Blood Pressure Parameters and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI )
Aim of this trial is to define if Post-Operative Cognitive Dysfunction and Delirium, 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.
Read the detailed description
Post-Operative Cognitive Dysfunction and Emergence Delirium has not been yet investigated after general anaesthesia with Targeted-Controlled-Infusion (TCI), daily used in the investigator's Hospital to anesthetize patients undergoing spinal surgery. Aim of this trial is to define if neurocognitive tests (Pfeiffer test, Montreal Cognitive Assessment, Trail Making Test A and B, Digit Span Test, Confusion Assessment Method) before and after surgery relate to concentrations at effector's site (Ec) of propofol and remifentanil TCI, the values of Bispectral Index, blood pressure values and usage of drugs to increase arterial blood pressure.
- 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 spinal-surgery patients detected with Montreal Cognitive Assessment test
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
Measured: 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)
Incidence of Post-Operative Cognitive Dysfunction in spinal-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
Measured: 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)
Incidence of Post-Operative Cognitive Dysfunction in spinal-surgery patients detected with Digit Span Test
Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Digit Span Test score and post-operative Digit Span Test test score
Measured: Patients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scores
Incidence of Emergence Delirium in spinal-surgery patients
Discover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 15 minutes after the awakening of patients
Measured: Patients will be subjected to CAM 15 minutes after the awakening after general anesthesia
Incidence of Emergence Delirium in spinal-surgery patients
Discover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 60 minutes after the awakening of patients
Measured: Patients will be subjected to CAM 60 minutes after the awakening after general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (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
- Collaborators
- Maran Eleonora
- Responsible party
- Principal investigator, Federico Linassi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950557
- Sponsor's protocol ID
- FLUO
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Cognitive Dysfunction and Delirium After Spinal Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data, Blood Pressure Parameters and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI )
- ClinicalTrials.gov ID
- NCT03950557
- Acronym / sponsor ID
- FLUO
- Keywords
- Infusion pumps, Intraoperative brain monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Maran Eleonora
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 May 2019 (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 and Delirium, 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.
Detailed description
Post-Operative Cognitive Dysfunction and Emergence Delirium has not been yet investigated after general anaesthesia with Targeted-Controlled-Infusion (TCI), daily used in the investigator's Hospital to anesthetize patients undergoing spinal surgery. Aim of this trial is to define if neurocognitive tests (Pfeiffer test, Montreal Cognitive Assessment, Trail Making Test A and B, Digit Span Test, Confusion Assessment Method) before and after surgery relate to concentrations at effector's site (Ec) of propofol and remifentanil TCI, the values of Bispectral Index, blood pressure values and usage of drugs to increase arterial blood pressure.
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
- Patients subjected to spinal surgery in general anaesthesia 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, Pfeiffer, CAM) the day before surgery, 15 and 60 minutes after awakening (only CAM) 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 intraoperative blood pressure values.
Key inclusion criteria (2 listed)
- General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
- Surgical duration > 60 minutes
Key exclusion criteria (1 listed)
- Neurological pathologies
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 spinal-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
Incidence of Post-Operative Cognitive Dysfunction in spinal-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
Incidence of Post-Operative Cognitive Dysfunction in spinal-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
Incidence of Emergence Delirium in spinal-surgery patients
Time frame: Patients will be subjected to CAM 15 minutes after the awakening after general anesthesia
Discover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 15 minutes after the awakening of patients
Incidence of Emergence Delirium in spinal-surgery patients
Time frame: Patients will be subjected to CAM 60 minutes after the awakening after general anesthesia
Discover Emergence Delirium analyzing Post-operative Confusion Assessment Method (CAM) delivered 60 minutes after the awakening of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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.
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 1 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: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 spinal-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)). The study lists 5 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 15 May 2019; AzTrials last refreshed its copy on 28 Oct 2026.