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

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)

Emergence Time — "perioperative"
Time to emergence from anesthesia:the time interval from discontinuation of anesthetics to patient awakening
Time for recovery of EEG index — Perioperative
The EEG index recovery time during emergence was monitored using the Misamo depth-of-anesthesia monitor. The awake judgment thresholds were set as SE ≥ 85 and RE ≥ 90. Shorter recovery time indicates rapid elimination of anesthetic suppression in the cerebral cortex and smoother emergence; significantly prolonged recovery time suggests accumulation of anesthetics and excessive cerebral cortical suppression. Start point: Discontinuation of maintenance doses of propofol, sevoflurane and remifentanil (rescue analgesics alone are not counted as the drug withdrawal start time). End point: The EEG index steadily reaches the awake threshold without decline for 10p

Trial sites (1)

Facility	City	Region	Status
General hospital of Ningxia medical university	Yinchuan	Ningxia	Recruiting

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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