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Postoperative Neurocognitive Disorders (PNCD)

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ClinicalTrials.gov Identifier: NCT04244162
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Rajesh Kumar, PhD, University of California, Los Angeles

Study Description
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Brief Summary:
The purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)) undergoing surgery. The investigators will enroll 50 OSA patients scheduled for surgery. All patients will have a brain scan (fMRI) within five days before surgery and two days and six months after surgery. During this visit cognitive function will be assessed using the Wide Range Assessment of Memory and Learning (WRAML2) and Montreal Cognitive Assessment (MoCA) tests. Patients will also be asked to participate in a blood draw during the first 2 visits for fMRI (within five days of surgery and two days after surgery). The Confusion Assessment Method (CAM-S) test, will be used to examine postoperative delirium.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Neurocognitive Disorders Diagnostic Test: Brain Imaging Diagnostic Test: Cognitive testing Diagnostic Test: Blood Biomarkers

Detailed Description:

The investigators will examine the potential mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)). This study proposes that neuro-inflammation is associated with measurable tissue changes that can be examined with MD measures and blood biomarkers.

On the day of surgery, standard of care procedures will take place. Hemodynamic vitals will be continuously monitored. As per the latest guidelines and recommendations from the American Society of Anesthesiologists (ASA), mean arterial pressure (MAP) will be targeted to > 60 mmHg or within 20% of baseline values, and processed EEG-guided anesthesia will be monitored to maintain a patient state index between 20-50. Electronic medical records and intraoperative integrated physiologic waveform will be collected.

In summary, the investigators will examine the potential mechanisms of brain injury contributing to postoperative delirium (POD) and acute and long-lasting neurocognitive deficits in an at-risk population (OSA).

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms Mediating Postoperative Neurocognitive Disorders
Actual Study Start Date : December 12, 2020
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Study Group
brain scans, cognitive tests, blood biomarkers
 Diagnostic Test: Brain Imaging
Magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI)-based mean diffusivity (MD) measures.

Diagnostic Test: Cognitive testing
Wide Range Assessment of Memory and Learning (WRAML2), Montreal Cognitive Assessment (MoCA), and Confusion Assessment Method for the ICU -severity (CAM-ICU S) tests.

Diagnostic Test: Blood Biomarkers
Inflammatory markers


Outcome Measures
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Primary Outcome Measures :
  1. Preoperative cognitive function [ Time Frame: pre-surgery (within five days before) ]
    Montreal Cognitive Assessment (MoCA) test

  2. Postoperative cognitive dysfunction - delayed cognitive recovery [ Time Frame: Post-surgery (within two days post surgery). ]
    Montreal Cognitive Assessment (MoCA) test

  3. Postoperative cognitive dysfunction - neurocognitive disorder [ Time Frame: Post-surgery (6 months after surgery). ]
    Montreal Cognitive Assessment (MoCA) test

  4. Preoperative cognitive function II [ Time Frame: pre-surgery (within five days before surgery) ]
    Wide Range Assessment of Memory and Learning (WRAML2)

  5. Postoperative cognitive dysfunction - delayed cognitive recovery II [ Time Frame: Post-surgery (within two days post surgery). ]
    Wide Range Assessment of Memory and Learning (WRAML2)

  6. Postoperative cognitive dysfunction - neurocognitive disorder II [ Time Frame: Post-surgery (6 months after surgery). ]
    Wide Range Assessment of Memory and Learning (WRAML2)

  7. Postoperative Delirium [ Time Frame: A two times per day for up to three days or discharge from the hospital. ]
    The Confusion Assessment Method (CAM-S) test


Secondary Outcome Measures :
  1. Blood Serum anti-inflammatory Biomarkers [ Time Frame: pre- (within five days before surgery) ]
    Assess blood inflammatory biomarkers (IL6, TNFa and IL1B) using enzyme-linked immunosorbent assay

  2. Blood Serum anti-inflammatory Biomarkers II [ Time Frame: post-surgery (within two days of surgery). ]
    Assess blood inflammatory biomarkers (IL6, TNFa and IL1B) using enzyme-linked immunosorbent assay

  3. Brain changes [ Time Frame: pre- (within five days before) and post-surgery (within two days and 6 months). ]
    Using non-invasive magnetic resonance imaging based diffusion tensor imaging

  4. Brain changes II [ Time Frame: Post-surgery (within two days post surgery). ]
    Using non-invasive magnetic resonance imaging based diffusion tensor imaging

  5. Brain changes III [ Time Frame: Post-surgery (within six months post surgery). ]
    Using non-invasive magnetic resonance imaging based diffusion tensor imaging


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index [AHI]>15 events/hour confirmed by overnight polysomnography),
Criteria

Inclusion Criteria:

Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index [AHI]>15 events/hour confirmed by overnight polysomnography), scheduled for open or robotic surgery (abdominal, gynecologic, or urologic), and upper or lower extremity orthopedic procedures

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04244162


Contacts
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Contact: Stephanie-Dee Sarovich 310.206.4484 ssarovich@mednet.ucla.edu
Contact: Jennifer Scovotti, MA 310.206.4484 jscovotti@mednet.ucla.edu

Locations
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United States, California
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine Recruiting
Los Angeles, California, United States, 90095
Contact: Stephanie-Dee Sarovich    310-206-4484    ssarovich@mednet.ucla.edu   
Contact: Jennifer Scovotti, MA    310.206.4484    jscovotti@mednet.ucla.edu   
Principal Investigator: Rajesh Kumar, PhD         
Principal Investigator: Susana Vacas, MD, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Rajesh Kumar, PhD University of California, Los Angeles
More Information
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Responsible Party: Rajesh Kumar, PhD, Assistant Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04244162    
Other Study ID Numbers: PNCD 19-001597
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajesh Kumar, PhD, University of California, Los Angeles:
brain imaging
neurocognitive testing
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Neurocognitive Disorders
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders