Pre-operative Neurocognitive Disorder and Low Near-infrared Spectrometry is Associated With Postoperative Delirium

NCT03171766 | Unknown

• 1 other identifier: 2016.253(216-DEFI/205-CES)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurocognitive Disorders; Postoperative Period; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• POD

  Incidence of Postoperative Disfunction

  From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.

Secondary Outcomes (3)

• Mortality

  From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.

• Complications

  From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.

• Hospital length of stay

  From day 1 to the last day in-hospital, if hospitalized for less than 3 days, or until day 3.

Interventions

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 test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years or older scheduled for elective Neurosurgery.

You may qualify if:

• patients aged 65 years or older scheduled for elective Neurosurgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead

Study Sites (1)

Centro Hospitalar do Porto

Porto, Portugal

RECRUITING

Related Publications (1)

• 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.

  PMID: 33002925 DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders; Postoperative Complications

Interventions

Visual Analog Scale

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maria J Susano, MD

  Centro Hospitalar do Porto

  PRINCIPAL INVESTIGATOR

• Humberto Machado, PhD

  Centro Hospitalar do Porto

  STUDY CHAIR

• Pedro Amorim, MD

  Centro Hospitalar do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Amorim, MD

CONTACT

+ 351 22 207 7549; amorpedro29f@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: May 31, 2017
• Study Start: June 15, 2017
• Primary Completion: October 15, 2017
• Study Completion: December 31, 2017
• Last Updated: June 26, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)