Postoperative Neurocognitive Disorders

Recruiting

• Conditions: Obstructive Sleep Apnea; Neurocognitive Disorders
• Interventions: Diagnostic Test: Brain Imaging; Diagnostic Test: Cognitive testing; Diagnostic Test: Blood Biomarkers

• Registration Number: NCT04244162
• Lead Sponsor: Massachusetts General Hospital

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).

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-28
• Study Start: 2020-12-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Primary Completion: 2024-02
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Brain Imaging	brain scans, cognitive tests, blood biomarkers
Study Group	Blood Biomarkers	brain scans, cognitive tests, blood biomarkers
Study Group	Cognitive testing	brain scans, cognitive tests, blood biomarkers

Primary Outcome Measures

Name	Time	Method
Postoperative cognitive dysfunction - delayed cognitive recovery	Post-surgery (within two days post surgery).	Montreal Cognitive Assessment (MoCA) test
Postoperative Delirium	A two times per day for up to three days or discharge from the hospital.	The Confusion Assessment Method (CAM-S) test
Preoperative cognitive function	pre-surgery (within five days before)	Montreal Cognitive Assessment (MoCA) test
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 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)

Secondary Outcome Measures

Name	Time	Method
Blood Serum anti-inflammatory Biomarkers	pre- (within five days before 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
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 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

Trial Locations

Locations (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine; 🇺🇸 Los Angeles, California, United States