Postoperative Neurocognitive Disorders
Kulcsszavak
Absztrakt
Leírás
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).
Dátumok
| Utolsó ellenőrzés: | 06/30/2020 |
| Első benyújtás: | 01/22/2020 |
| Becsült beiratkozás benyújtva: | 01/23/2020 |
| Első közzététel: | 01/27/2020 |
| Utolsó frissítés beküldve: | 07/20/2020 |
| Utolsó frissítés közzétéve: | 07/22/2020 |
| A tanulmány tényleges kezdési dátuma: | 09/30/2020 |
| Becsült elsődleges befejezési dátum: | 04/30/2023 |
| A tanulmány becsült befejezési dátuma: | 07/31/2023 |
Állapot vagy betegség
Beavatkozás / kezelés
Diagnostic Test: Study Group
Diagnostic Test: Study Group
Diagnostic Test: Study Group
Fázis
Karcsoportok
| Kar | Beavatkozás / kezelés |
|---|---|
| Study Group brain scans, cognitive tests, blood biomarkers | Diagnostic Test: Study Group Magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI)-based mean diffusivity (MD) measures. |
Jogosultsági kritériumok
| Tanulásra alkalmas korok | 40 Years Nak nek 40 Years |
| Tanulásra alkalmas nemek | All |
| Mintavételi módszer | Non-Probability Sample |
| Egészséges önkénteseket fogad | Igen |
| Kritériumok | 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 |
Eredmény
Elsődleges eredménymérők
1. Preoperative cognitive function [pre-surgery (within five days before)]
2. Postoperative cognitive dysfunction - delayed cognitive recovery [Post-surgery (within two days post surgery).]
3. Postoperative cognitive dysfunction - neurocognitive disorder [Post-surgery (6 months after surgery).]
4. Preoperative cognitive function II [pre-surgery (within five days before surgery)]
5. Postoperative cognitive dysfunction - delayed cognitive recovery II [Post-surgery (within two days post surgery).]
6. Postoperative cognitive dysfunction - neurocognitive disorder II [Post-surgery (6 months after surgery).]
7. Postoperative Delirium [A two times per day for up to three days or discharge from the hospital.]
Másodlagos eredménymérők
1. Blood Serum anti-inflammatory Biomarkers [pre- (within five days before surgery)]
2. Blood Serum anti-inflammatory Biomarkers II [post-surgery (within two days of surgery).]
3. Brain changes [pre- (within five days before) and post-surgery (within two days and 6 months).]
4. Brain changes II [Post-surgery (within two days post surgery).]
5. Brain changes III [Post-surgery (within six months post surgery).]
