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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorGeneral Hospital of Ningxia Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

- 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;

Disqualifiers

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;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Exposed cohort (sleep disorder group)1 intervention
Group B: Control cohort (non-sleep disorder group)1 intervention

Trial outcomes

Primary outcomes

1

Emergence Time

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

Time frame
"perioperative"
2

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

Time frame
Perioperative

Secondary outcomes

1

Dosage of anesthetics:

Dosage of anesthetics: total consumption of propofol, remifentanil and sevoflurane administered from anesthesia induction to emergence.

Time frame
Perioperative
2

incidence of postoperative delirium

Postoperative delirium was assessed using the Confusion Assessment Method (CAM), which evaluates four dimensions: 1. acute fluctuating course; 2. inattention; 3. disorganized thinking; 4. altered level of consciousness. Higher CAM scores indicate more severe delirium. Score 0: No delirium Score 1-2: Subsyndromal delirium (mild early stage) Score ≥3: Confirmed delirium Score 5-7: Severe delirium

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

Numerical Rating Scale (NRS) pain score

The Numerical Rating Scale (NRS) was adopted to evaluate the postoperative pain trend from postoperative Day 1 to Day 7. Higher NRS scores indicate more severe pain.Scores of 1-3 indicate mild pain, 4-7 moderate pain, and 8-10 severe pain.

Time frame
Pain scores were recorded immediately after surgery and daily from postoperative Day 1 to Day 7.
4

Incidence of postoperative nausea and vomiting (PONV)

Grade 0 No nausea or vomiting Normal Grade 1 Nausea only, no vomiting or retching Mild PONV Grade 2 Retching or intermittent vomiting, less than 2 episodes Moderate PONV Grade 3 Frequent vomiting (≥2 episodes) with gastric contents ejection Severe PONV requiring pharmacological intervention For patients with Grade 2 or above PONV, the event shall be recorded in the Adverse Event section of the CRF, with a notation on whether antiemetics are administered.

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

Other outcomes

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