Postoperative Neurocognitive Disorders (PNCD)

October 31, 2025 updated by: Susana Vacas, MD, PhD, Massachusetts General Hospital

Mechanisms Mediating 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

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),

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative cognitive function
Time Frame: pre-surgery (within five days before)
Montreal Cognitive Assessment (MoCA) test
pre-surgery (within five days before)
Postoperative cognitive dysfunction - delayed cognitive recovery
Time Frame: Post-surgery (within two days post surgery).
Montreal Cognitive Assessment (MoCA) test
Post-surgery (within two days post surgery).
Postoperative cognitive dysfunction - neurocognitive disorder
Time Frame: Post-surgery (6 months after surgery).
Montreal Cognitive Assessment (MoCA) test
Post-surgery (6 months after surgery).
Preoperative cognitive function II
Time Frame: pre-surgery (within five days before surgery)
Wide Range Assessment of Memory and Learning (WRAML2)
pre-surgery (within five days before surgery)
Postoperative cognitive dysfunction - delayed cognitive recovery II
Time Frame: Post-surgery (within two days post surgery).
Wide Range Assessment of Memory and Learning (WRAML2)
Post-surgery (within two days post surgery).
Postoperative cognitive dysfunction - neurocognitive disorder II
Time Frame: Post-surgery (6 months after surgery).
Wide Range Assessment of Memory and Learning (WRAML2)
Post-surgery (6 months after surgery).
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
A two times per day for up to three days or discharge from the hospital.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre- (within five days before surgery)
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
post-surgery (within two days of surgery).
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
pre- (within five days before) and post-surgery (within two days and 6 months).
Brain changes II
Time Frame: Post-surgery (within two days post surgery).
Using non-invasive magnetic resonance imaging based diffusion tensor imaging
Post-surgery (within two days post surgery).
Brain changes III
Time Frame: Post-surgery (within six months post surgery).
Using non-invasive magnetic resonance imaging based diffusion tensor imaging
Post-surgery (within six months post surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Rajesh Kumar, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2020

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 31, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNCD 19-001597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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