Postoperative Neurocognitive Disorders

Obstructive Sleep Apnea Clinical Trial

— PNCD  

Official title:

Mechanisms Mediating Postoperative Neurocognitive Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04244162
• Other study ID #: PNCD 19-001597
• Status: Recruiting
• Start date: December 12, 2020
• Est. completion date: August 2024

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: Stephanie-Dee Sarovich
• Phone: 310.206.4484
• Email: ssarovich[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurocognitive Disorders
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Brain Imaging
Magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI)-based mean diffusivity (MD) measures.
• 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.
• Blood Biomarkers
Inflammatory markers

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative cognitive function	Montreal Cognitive Assessment (MoCA) test	pre-surgery (within five days before)
Primary	Postoperative cognitive dysfunction - delayed cognitive recovery	Montreal Cognitive Assessment (MoCA) test	Post-surgery (within two days post surgery).
Primary	Postoperative cognitive dysfunction - neurocognitive disorder	Montreal Cognitive Assessment (MoCA) test	Post-surgery (6 months after surgery).
Primary	Preoperative cognitive function II	Wide Range Assessment of Memory and Learning (WRAML2)	pre-surgery (within five days before surgery)
Primary	Postoperative cognitive dysfunction - delayed cognitive recovery II	Wide Range Assessment of Memory and Learning (WRAML2)	Post-surgery (within two days post surgery).
Primary	Postoperative cognitive dysfunction - neurocognitive disorder II	Wide Range Assessment of Memory and Learning (WRAML2)	Post-surgery (6 months after surgery).
Primary	Postoperative Delirium	The Confusion Assessment Method (CAM-S) test	A two times per day for up to three days or discharge from the hospital.
Secondary	Blood Serum anti-inflammatory Biomarkers	Assess blood inflammatory biomarkers (IL6, TNFa and IL1B) using enzyme-linked immunosorbent assay	pre- (within five days before surgery)
Secondary	Blood Serum anti-inflammatory Biomarkers II	Assess blood inflammatory biomarkers (IL6, TNFa and IL1B) using enzyme-linked immunosorbent assay	post-surgery (within two days of surgery).
Secondary	Brain changes	Using non-invasive magnetic resonance imaging based diffusion tensor imaging	pre- (within five days before) and post-surgery (within two days and 6 months).
Secondary	Brain changes II	Using non-invasive magnetic resonance imaging based diffusion tensor imaging	Post-surgery (within two days post surgery).
Secondary	Brain changes III	Using non-invasive magnetic resonance imaging based diffusion tensor imaging	Post-surgery (within six months post surgery).