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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03171766 |
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Date of registration:
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29/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium
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Scientific title:
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Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium in Neurosurgical Patients |
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Date of first enrolment:
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June 15, 2017 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03171766 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Pedro Amorim, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Pedro Amorim, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar do Porto |
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Name:
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Pedro Amorim, MD |
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Address:
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Telephone:
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+ 351 22 207 7549 |
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Email:
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amorpedro29f@gmail.com |
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Affiliation:
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Name:
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Humberto Machado, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar do Porto |
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Name:
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Maria J Susano, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar do Porto |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients aged 65 years or older scheduled for elective Neurosurgery
Exclusion Criteria:
- 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.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neurocognitive Disorders
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Postoperative Complications
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Postoperative Period
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Intervention(s)
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Diagnostic Test: Mini-Mental State Examination (MMSE)
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Diagnostic Test: Mini Cog test
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Diagnostic Test: Visual Analog Scale (VAS)
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Primary Outcome(s)
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POD
[Time Frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.]
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Secondary Outcome(s)
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Complications
[Time Frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.]
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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.]
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Mortality
[Time Frame: From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.]
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Secondary ID(s)
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2016.253(216-DEFI/205-CES)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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