Tokyo, April 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061309) titled 'A prospective observational study on the association between preoperative sleep quality, intraoperative EEG, and postoperative delirium' on April 20.

Study Type: Observational

Primary Sponsor: Institute - Hitachi General Hospital

Condition: Condition - Perioperative brain vulnerability (postoperative delirium) in patients aged 65 years or older undergoing elective surgery under general anesthesia Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To clarify the association between preoperative sleep quality (PSQI global score) and intraoperative frontal alpha power (8~12 Hz relative power) derived from SedLine EEG during the maintenance phase of general anesthesia. Further, to examine whether intraoperative alpha power mediates the relationship between PSQI and postoperative delirium (POD) through an exploratory mediation analysis. Secondary aims include assessing the association of PSQI components and other EEG spectral features (alpha-to-delta ratio, SEF95, burst suppression ratio, permutation entropy) with the primary exposure, as well as postoperative sleep quality (J RCSQ). Basic objectives2 - Safety

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Aged 65 years or older at the time of informed consent. 2. Scheduled for elective surgery under general anesthesia with propofol induction and desflurane maintenance as part of routine clinical care. 3. Scheduled surgery duration of 90 minutes or more. 4. ASA-PS I, II, or III. 5. Able to complete preoperative assessments including PSQI, Mini-Cog, and GDS-15. 6. Written informed consent obtained after adequate explanation of the study. Key exclusion criteria - 1. Emergency surgery. 2. Neurosurgery. 3. Patients in whom frontal SedLine sensor placement is difficult (e.g., skin disorders, trauma). 4. Preoperative Mini-Cog score less than 3 (suspected cognitive impairment). 5. History of psychiatric disorders (schizophrenia, bipolar disorder). 6. History of cerebrovascular disease (cerebral infarction, cerebral hemorrhage, transient ischemic attack). 7. History of epilepsy. 8. Obstructive sleep apnea syndrome under ongoing CPAP therapy. 9. Cases in which intraoperative EEG recording required for the primary analysis cannot be obtained. 10. Other cases judged inappropriate by the principal investigator. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2016 Year 03 Month 15 Day Anticipated trial start date - 2026 Year 04 Month 25 Day Last follow-up date - 2026 Year 12 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070152

Disclaimer: Curated by HT Syndication.