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Clinical Trials in China / NCT07675993
Recruiting Observational

Effects of Preoperative Sleep Disorders on Perioperative Anesthesia Depth and Recovery Quality in Patients Undergoing Noncardiac Surgery

NCT07675993 · tracked via the Priya Life Science China tracker
Sponsor
General Hospital of Ningxia Medical University
Phase
Observational
Started
2026-06-16
Last updated
2026-06-30

Condition(s) studied

Emergence Time

Investigational drug(s) / intervention(s)

Exposed cohort (sleep disorder group)Control cohort (non-sleep disorder group)

Exposed cohort (sleep disorder group): All participants receive standardized sevoflurane-based general anesthesia for elective non-cardiac surgery. Continuous perioperative electroencephalographic (EEG) monitoring is performed throughout induction, maintenance and emergence phase. Serial scale assessments including PSQI, PSG, MMSE, NRS and delirium evaluation, as well as serial serum BDNF testing are conducted at designated perioperative time points. This cohort consists of patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥ 7, defined as preoperative sleep disorders.

Control cohort (non-sleep disorder group): All participants receive identical standardized sevoflurane-based general anesthesia and continuous full-course EEG monitoring during elective non-cardiac surgery. Uniform perioperative scale assessments (PSQI, PSG, MMSE, NRS, postoperative delirium screening) and serial serum BDNF detection are completed at unified time nodes. This control cohort includes patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score \< 7 without preoperative sleep disturbance.

Study summary

A Single-Center, Prospective Observational Cohort Study Comparing Perioperative Electroencephalographic Anesthesia Depth Parameters (Electroencephalographic Index, SE/RE Entropy, Burst Suppression Ratio) Between Patients With Preoperative Sleep Disorders and Those Without; To Identify the Independent Effects of Preoperative Sleep Disorders on the Speed of Electroencephalographic Recovery During Emergence, Electroencephalographic Status at Extubation, Intra-PACU Electroencephalographic Fluctuations, and Quality of Emergence.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. \- Aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ; 2. Elective non-cardiac surgery with an expected operative duration longer than 2 hours; 3. Preoperative Mini-Mental State Examination (MMSE) score ≥ 24; 4. Completion of the Pittsburgh Sleep Quality Index (PSQI) assessment 1 day before surgery; 5. Absence of severe cardiac, hepatic, renal or cerebral diseases, and no history of psychiatric or neurological disorders; 6. Voluntary provision of written informed consent. Exclusion Criteria: 1. Preoperative severe cognitive dysfunction, history of traumatic brain injury or stroke; 2. Long-term regular use of sedative-hypnotics, antidepressants or antipsychotics; 3. Intraoperative massive hemorrhage, cardiac arrest, or severe hypoxemia (SpO₂ \< 90% lasting for more than 5 minutes); 4. Inability to cooperate with EEG monitoring or scale evaluation; 5. Pregnancy or breastfeeding status. Drop-out Criteria : 1. Cancellation of scheduled surgery/anesthesia or postoperative admission to the intensive care unit (ICU); 2. Patient withdrawal of study participation; 3. Intraoperative massive hemorrhage, cardiac arrest, or severe hypoxemia (SpO₂ \< 90% lasting for more than 5 minutes); 4. Development of severe postoperative complications; 5. Incomplete data collection or voluntary trial withdrawal.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
General hospital of Ningxia medical university Yinchuan Ningxia Recruiting

More General Hospital of Ningxia Medical University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07675993 on ClinicalTrials.gov ↗ ← All trials in China