Clinical trial NCT04244162: Postoperative Neurocognitive Disorders
Official title: Mechanisms Mediating Postoperative Neurocognitive Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Neurocognitive Disorders
Keywords: brain imaging
neurocognitive testing
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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),

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.

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).

Eligibility 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

Primary outcomes:
measure: Preoperative cognitive function
timeFrame: pre-surgery (within five days before)
measure: Postoperative cognitive dysfunction - delayed cognitive recovery
timeFrame: Post-surgery (within two days post surgery).
measure: Postoperative cognitive dysfunction - neurocognitive disorder
timeFrame: Post-surgery (6 months after surgery).
measure: Preoperative cognitive function II
timeFrame: pre-surgery (within five days before surgery)
measure: Postoperative cognitive dysfunction - delayed cognitive recovery II
timeFrame: Post-surgery (within two days post surgery).
measure: Postoperative cognitive dysfunction - neurocognitive disorder II
timeFrame: Post-surgery (6 months after surgery).
measure: Postoperative Delirium
timeFrame: A two times per day for up to three days or discharge from the hospital.
Secondary outcomes:
measure: Blood Serum anti-inflammatory Biomarkers
timeFrame: pre- (within five days before surgery)
measure: Blood Serum anti-inflammatory Biomarkers II
timeFrame: post-surgery (within two days of surgery).
measure: Brain changes
timeFrame: pre- (within five days before) and post-surgery (within two days and 6 months).
measure: Brain changes II
timeFrame: Post-surgery (within two days post surgery).
measure: Brain changes III
timeFrame: Post-surgery (within six months post surgery).
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Rajesh Kumar, PhD
role: PRINCIPAL_INVESTIGATOR
References: