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NCT Number: NCT04244162

Postoperative Neurocognitive Disorders

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurocognitive Disorders Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Los Angeles, California, 90095, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brain imaging

Diagnostic Test

Magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI)-based mean diffusivity (MD) measures.

Cognitive Testing

Diagnostic Test

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

Blood Biomarkers

Diagnostic Test

Inflammatory markers

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Mechanisms Mediating Postoperative Neurocognitive Disorders

Acronym: PNCD

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jan 28, 2020
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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