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A prospective observational study on the association between preoperative sleep quality, intraoperative EEG, and postoperative delirium

Association of Preoperative Sleep Quality (PSQI) With Intraoperative SedLine-Derived Frontal EEG Spectral Features and Mediation of Postoperative Delirium in Older Surgical Patients: A Single-Center Prospective Observational Study - PSQI-alphaPOD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061309
Enrollment
150
Registered
2026-04-20
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative brain vulnerability (postoperative delirium) in patients aged 65 years or older undergoing elective surgery under general anesthesia

Interventions

None listed

Sponsors

Hitachi General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 50 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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Association between preoperative PSQI global score (continuous variable) and SedLine-derived frontal alpha power (8~12 Hz relative power, averaged across four channels) during the maintenance phase of general anesthesia.

Secondary

MeasureTime frame
1) Postoperative delirium (POD): assessed twice daily on POD1-3 using the 3D-CAM; POD is defined as positive if any assessment is positive across POD1-3. 2) Exploratory mediation analysis of PSQI -> frontal alpha power -> POD (Bootstrap 5,000 resamples, bias-corrected accelerated 95% confidence interval). 3) Associations between other EEG spectral features (alpha-to-delta ratio, SEF95, burst suppression ratio, permutation entropy) and PSQI. 4) Associations between individual PSQI components (C1 subjective sleep quality, C2 sleep latency, C3 sleep duration, C4 habitual sleep efficiency, C5 sleep disturbances, C6 use of sleep medication, C7 daytime dysfunction) and alpha power (Bonferroni correction). 5) Comparison of EEG spectral features between POD and non-POD groups. 6) Postoperative sleep quality: J-RCSQ assessed every morning on POD1-3; the three-day mean is the analytic value. Independent predictors explored by multiple regression. 7) Independent contribution of PSQI to alpha power in partial correlation and multivariable linear regression adjusted for age, Mini-Cog, GDS-15, CFS, and aaMAC.

Countries

Japan

Contacts

Public ContactTakuya Shiraishi

Hitachi General Hospital Department of Anesthesiology

tshiraishi.1217@gmail.com0294-23-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026