PNCD: Postoperative Neurocognitive Disorders
Study Details
Study Description
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 | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | 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
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Outcome Measures
Primary Outcome Measures
- Preoperative cognitive function [pre-surgery (within five days before)]
Montreal Cognitive Assessment (MoCA) test
- Postoperative cognitive dysfunction - delayed cognitive recovery [Post-surgery (within two days post surgery).]
Montreal Cognitive Assessment (MoCA) test
- Postoperative cognitive dysfunction - neurocognitive disorder [Post-surgery (6 months after surgery).]
Montreal Cognitive Assessment (MoCA) test
- Preoperative cognitive function II [pre-surgery (within five days before surgery)]
Wide Range Assessment of Memory and Learning (WRAML2)
- Postoperative cognitive dysfunction - delayed cognitive recovery II [Post-surgery (within two days post surgery).]
Wide Range Assessment of Memory and Learning (WRAML2)
- Postoperative cognitive dysfunction - neurocognitive disorder II [Post-surgery (6 months after surgery).]
Wide Range Assessment of Memory and Learning (WRAML2)
- Postoperative Delirium [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
- Blood Serum anti-inflammatory Biomarkers [pre- (within five days before surgery)]
Assess blood inflammatory biomarkers (IL6, TNFa and IL1B) using enzyme-linked immunosorbent assay
- Blood Serum anti-inflammatory Biomarkers II [post-surgery (within two days of surgery).]
Assess blood inflammatory biomarkers (IL6, TNFa and IL1B) using enzyme-linked immunosorbent assay
- Brain changes [pre- (within five days before) and post-surgery (within two days and 6 months).]
Using non-invasive magnetic resonance imaging based diffusion tensor imaging
- Brain changes II [Post-surgery (within two days post surgery).]
Using non-invasive magnetic resonance imaging based diffusion tensor imaging
- Brain changes III [Post-surgery (within six months post surgery).]
Using non-invasive magnetic resonance imaging based diffusion tensor imaging
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
Investigators
- Principal Investigator: Susana Vacas, MD, PhD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PNCD 19-001597