Neurocognitive DisordersNCT03171766
Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium
An observational study of Neurocognitive Disorders and Postoperative Period, run by Centro Hospitalar do Porto at 1 site in Portugal.
Trial summary
The main goal of the investigation is to identify the incidence of cognitive dysfunction and POD in patients older than 65 years of age undergoing neurosurgical elective surgery and determine if an association between cognitive dysfunction, basal NIRS and POD exists. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neurocognitive Disorders, Postoperative Period, Postoperative Complications
- What is being tested?
- Mini-Mental State Examination (MMSE), Visual Analog Scale (VAS) and Mini Cog test
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Jun 2017to 31 Dec 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years or older scheduled for elective Neurosurgery.
Who may be able to join
- patients aged 65 years or older scheduled for elective Neurosurgery
Who cannot join
- refusal to give informed consent; inability to understand and cooperate to perform the Mini Cog test, Mini Mental State Examination (MMSE) and Visual Analog Scale (VAS) for pain score (including aphasia, motor disability, major neurocognitive disorder, etc); previous dementia documented on clinical records and Portuguese not first language.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar do Porto
Porto
Pedro Amorim, MD
About this study
Official title: Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium in Neurosurgical Patients
The main goal of the investigation is to identify the incidence of cognitive dysfunction and POD in patients older than 65 years of age undergoing neurosurgical elective surgery and determine if an association between cognitive dysfunction, basal NIRS and POD exists.
Read the detailed description
Postoperative delirium (POD) is a common problem among elders who undergo surgery and anesthesia, with major health consequences. This investigation is expected to clarify and understand the role of neurocognitive reserve in the occurrence of POD, provide grounds to preoperative cognitive risk stratification and early preventive interventions to improve patients' outcomes. The surgical procedure and anesthesia are stressor events that interact with underlying risk factors and play an important role in the development of POD. Evidence is lacking to make recommendations on anesthesia related perioperative interventions. This investigation will contribute to better understand the association between types of anesthesia, medications, monitoring and other anesthesia related factors that can be a target for preventive interventions. This research will add knowledge and clarify the role of predictors and precipitant factors that might enlighten future research on risk stratification models and interventions, prognostic significance, and treatment implications for POD.
All patients scheduled for Neurosurgery will be approached the day before surgery to assess if inclusion criteria are met and obtain informed consent. If so, preoperative evaluation will be performed by two nurse investigators responsible for admission of patients in the Neurosurgical ward.
The Mini-Cog test and the will be administered before surgery to all participants as cognitive assessment tool. The social-economical status will be evaluated regarding the level of education in years, level of physical activity, occupation, income and number of languages spoken (all categorized with appropriate scales). Also, during the preoperative evaluation, demographic data, alcohol consumption, smoking, use of visual or hearing aids, comorbidities, usual medication and preoperative laboratory test results will be obtained and recorded in a form. On the day of the surgery, as the patient arrives at the Operating Room (OR), the anesthesiologist will check for informed consent and the patient will be monitored with the following with the standard ASA protocol.
The Near-infrared spectroscopy (NIRS) is a technology widely used in clinical investigation as an index of brain and tissue oxygenation. The INVOS© Cerebral/Somatic Oximetry is used in high-risk patients or surgeries to provide continuous, real-time, regional oxygen saturation (rSO2. The monitoring parameters, excluding the INVOS©, will be continuously recorded on the software program RugloopII© Waves (Demed, Genk, Belgium).
In the Post-Anesthesia Care Unit (PACU) the infrared pupillometer will be used to measure the patient pupillary reflexes 15 minutes after admission and before PACU discharge.
All included patients will be followed postoperatively from day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3. The investigator nurse will apply the Nu-DESC daily as a tool to screen delirium. The CAM will be applied to diagnose delirium if the patient is screened with POD. Pain will be evaluated using a standard 100mm VAS for pain (VAS=0 no pain, VAS=100 worst pain). Before hospital discharge all participants will retake the Mini-Cog test and the MMSE.
- Being tested
- Mini-Mental State Examination (MMSE), Visual Analog Scale (VAS), Mini Cog test
- Medical subject headings
- Neurocognitive Disorders, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Mental State Examination (MMSE)Diagnostic test
It is simple scored form of the cognitive mental status examination which includes eleven questions and requires only 5 to 10 minutes.
Visual Analog Scale (VAS)Diagnostic test
Visual Analog Scale (VAS) for pain score (including aphasia, motor disability, major neurocognitive disorder, etc)
Mini Cog testDiagnostic test
The Mini-Cog© test is another validated and simple tool to screen for dementia and cognitive dysfunction. It measures the cognitive reserve at the time of acute stress with a low degree of interobserver variability.
What is being measured
The primary outcome is the main question the study is designed to answer.
POD
Incidence of Postoperative Disfunction
Measured: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
Secondary outcomes (3)
Mortality
Occurrence of In-hospital mortality
Measured: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
Complications
Occurrence of Postoperative complications
Measured: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
Hospital length of stay
Hospital length of stay
Measured: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start15 Jun 2017
- Primary completion15 Oct 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisordersStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Amorim, MD, Centro Hospitalar do Porto
- Investigators
- Maria J Susano, MD, Principal investigator, Centro Hospitalar do PortoHumberto Machado, PhD, Study chair, Centro Hospitalar do PortoPedro Amorim, MD, Principal investigator, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171766
- Sponsor's protocol ID
- 2016.253(216-DEFI/205-CES)
- Status last verified
- Jun 2017
- First submitted
- 29 May 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Susano MJ, Dias M, Seixas FS, Vide S, Grasfield R, Abelha FJ, Crosby G, Culley DJ, Amorim P. Association Among Preoperative Cognitive Performance, Regional Cerebral Oxygen Saturation, and Postoperative Delirium in Older Portuguese Patients. Anesth Analg. 2021 Mar 1;132(3):846-855. doi: 10.1213/ANE.0000000000005159.
PubMed 33002925
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT03171766
- Acronym / sponsor ID
- 2016.253(216-DEFI/205-CES)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Oct 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 31 May 2017 (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.
The main goal of the investigation is to identify the incidence of cognitive dysfunction and POD in patients older than 65 years of age undergoing neurosurgical elective surgery and determine if an association between cognitive dysfunction, basal NIRS and POD exists.
Detailed description
Postoperative delirium (POD) is a common problem among elders who undergo surgery and anesthesia, with major health consequences. This investigation is expected to clarify and understand the role of neurocognitive reserve in the occurrence of POD, provide grounds to preoperative cognitive risk stratification and early preventive interventions to improve patients' outcomes. The surgical procedure and anesthesia are stressor events that interact with underlying risk factors and play an important role in the development of POD. Evidence is lacking to make recommendations on anesthesia related perioperative interventions. This investigation will contribute to better understand the association between types of anesthesia, medications, monitoring and other anesthesia related factors that can be a target for preventive interventions. This research will add knowledge and clarify the role of predictors and precipitant factors that might enlighten future research on risk stratification models and interventions, prognostic significance, and treatment implications for POD.
All patients scheduled for Neurosurgery will be approached the day before surgery to assess if inclusion criteria are met and obtain informed consent. If so, preoperative evaluation will be performed by two nurse investigators responsible for admission of patients in the Neurosurgical ward.
The Mini-Cog test and the will be administered before surgery to all participants as cognitive assessment tool. The social-economical status will be evaluated regarding the level of education in years, level of physical activity, occupation, income and number of languages spoken (all categorized with appropriate scales). Also, during the preoperative evaluation, demographic data, alcohol consumption, smoking, use of visual or hearing aids, comorbidities, usual medication and preoperative laboratory test results will be obtained and recorded in a form. On the day of the surgery, as the patient arrives at the Operating Room (OR), the anesthesiologist will check for informed consent and the patient will be monitored with the following with the standard ASA protocol.
The Near-infrared spectroscopy (NIRS) is a technology widely used in clinical investigation as an index of brain and tissue oxygenation. The INVOS© Cerebral/Somatic Oximetry is used in high-risk patients or surgeries to provide continuous, real-time, regional oxygen saturation (rSO2. The monitoring parameters, excluding the INVOS©, will be continuously recorded on the software program RugloopII© Waves (Demed, Genk, Belgium).
In the Post-Anesthesia Care Unit (PACU) the infrared pupillometer will be used to measure the patient pupillary reflexes 15 minutes after admission and before PACU discharge.
All included patients will be followed postoperatively from day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3. The investigator nurse will apply the Nu-DESC daily as a tool to screen delirium. The CAM will be applied to diagnose delirium if the patient is screened with POD. Pain will be evaluated using a standard 100mm VAS for pain (VAS=0 no pain, VAS=100 worst pain). Before hospital discharge all participants will retake the Mini-Cog test and the MMSE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years or older scheduled for elective Neurosurgery.
Key inclusion criteria (1 listed)
- patients aged 65 years or older scheduled for elective Neurosurgery
Key exclusion criteria (1 listed)
- refusal to give informed consent; inability to understand and cooperate to perform the Mini Cog test, Mini Mental State Examination (MMSE) and Visual Analog Scale (VAS) for pain score (including aphasia, motor disability, major neurocognitive disorder, etc); previous dementia documented on clinical records and Portuguese not first language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-Mental State Examination (MMSE)It is simple scored form of the cognitive mental status examination which includes eleven questions and requires only 5 to 10 minutes. | Diagnostic test | – |
| Visual Analog Scale (VAS)Visual Analog Scale (VAS) for pain score (including aphasia, motor disability, major neurocognitive disorder, etc) | Diagnostic test | – |
| Mini Cog testThe Mini-Cog© test is another validated and simple tool to screen for dementia and cognitive dysfunction. It measures the cognitive reserve at the time of acute stress with a low degree of interobserver variability. | Diagnostic test | – |
Primary outcome
POD
Time frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
Incidence of Postoperative Disfunction
3 secondary outcomes
Mortality
Time frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
Complications
Time frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
Hospital length of stay
Time frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Derived from this study: PubMed 33002925Susano MJ, Dias M, Seixas FS, Vide S, Grasfield R, Abelha FJ, Crosby G, Culley DJ, Amorim P. Association Among Preoperative Cognitive Performance, Regional Cerebral Oxygen Saturation, and Postoperative Delirium in Older Portuguese Patients. Anesth Analg. 2021 Mar 1;132(3):846-855. doi: 10.1213/ANE.0000000000005159.
- Individual participant dataSharing planned: No
Related trials for Neurocognitive Disorders
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Maria J Susano, MD principal investigator
Centro Hospitalar do Porto
Humberto Machado, PhD study chair
Centro Hospitalar do Porto
Pedro Amorim, MD principal investigator
Centro Hospitalar do Porto
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 Neurocognitive Disorders and Postoperative Period, run by Centro Hospitalar do Porto at 1 site in Portugal.
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 1 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 26 Jun 2017. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Amorim, MD (+ 351 22 207 7549, amorpedro29f@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POD (time frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171766, which also lists 1 linked publication.
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 26 Jun 2017.