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

NCT07675993 | Recruiting DMC

• 1 other identifier: ZN-2026-0615
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergence Time

Keywords

sleep disorders; sevoflurane anesthesia; delayed emergence

Outcome Measures

Primary Outcomes (2)

• Emergence Time

  Time to emergence from anesthesia:the time interval from discontinuation of anesthetics to patient awakening

  "perioperative"

• Time for recovery of EEG index

  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

  Perioperative

Secondary Outcomes (4)

• Dosage of anesthetics:

  Perioperative

• incidence of postoperative delirium

  CAM assessments were performed and recorded on postoperative Day 1, Day 3 and Day 7.

• Numerical Rating Scale (NRS) pain score

  Pain scores were recorded immediately after surgery and daily from postoperative Day 1 to Day 7.

• Incidence of postoperative nausea and vomiting (PONV)

  PONV assessments were conducted upon emergence from anesthesia after surgery, and on postoperative Day 1, Day 2 and Day 3.

Study Arms (2)

Exposed cohort (sleep disorder group)

Patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score ≥7.

Combination Product: Exposed cohort (sleep disorder group)

Control cohort (non-sleep disorder group)

Patients with preoperative Pittsburgh Sleep Quality Index (PSQI) score \<7.

Combination Product: Control cohort (non-sleep disorder group)

Interventions

Control cohort (non-sleep disorder group) COMBINATION_PRODUCT

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.

Control cohort (non-sleep disorder group)

Exposed cohort (sleep disorder group) COMBINATION_PRODUCT

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.

Exposed cohort (sleep disorder group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective non-cardiac surgery under general anesthesia at our hospital will be enrolled in this study.

You may qualify if:

• \- Aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status classification Ⅰ-Ⅲ;
• Elective non-cardiac surgery with an expected operative duration longer than 2 hours;
• Preoperative Mini-Mental State Examination (MMSE) score ≥ 24;
• Completion of the Pittsburgh Sleep Quality Index (PSQI) assessment 1 day before surgery;
• Absence of severe cardiac, hepatic, renal or cerebral diseases, and no history of psychiatric or neurological disorders;
• Voluntary provision of written informed consent.

You may not qualify if:

• Preoperative severe cognitive dysfunction, history of traumatic brain injury or stroke;
• Long-term regular use of sedative-hypnotics, antidepressants or antipsychotics;
• Intraoperative massive hemorrhage, cardiac arrest, or severe hypoxemia (SpO₂ \< 90% lasting for more than 5 minutes);
• Inability to cooperate with EEG monitoring or scale evaluation;
• Pregnancy or breastfeeding status.
• Drop-out Criteria :
• Cancellation of scheduled surgery/anesthesia or postoperative admission to the intensive care unit (ICU);
• Patient withdrawal of study participation;
• Intraoperative massive hemorrhage, cardiac arrest, or severe hypoxemia (SpO₂ \< 90% lasting for more than 5 minutes);
• Development of severe postoperative complications;
• Incomplete data collection or voluntary trial withdrawal.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General hospital of Ningxia medical university

Yinchuan, Ningxia, 750001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Brain-Derived Neurotrophic Factor (BDNF) levels measured preoperatively and postoperatively.

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

NA Zhao, Doctoral Candidate

CONTACT

86-951-674-3252; 18995096494@163.com

Li Xin Ni, Doctoral

CONTACT

86-951-674-3252

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 30, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)