Perioperative EEG Prediction of Postoperative Sleep Disturbance in Gynecologic Laparoscopic Surgery
Perioperative Electroencephalographic Features for Predicting Postoperative Sleep Disturbance in Patients Undergoing Gynecologic Laparoscopic Surgery: A Prospective Observational Cohort Study
Postoperative sleep disturbance is common in patients undergoing gynecologic surgery and may affect postoperative recovery. This prospective observational cohort study will evaluate perioperative EEG changes in patients undergoing gynecologic laparoscopic surgery and examine their association with postoperative sleep disturbance.
Approximately 300 adult patients will be enrolled. Frontal EEG will be recorded during the perioperative period, and relevant clinical information will be collected. Postoperative sleep and recovery will be assessed using standardized questionnaires. EEG features and clinical variables will then be analyzed to determine which factors are associated with postoperative sleep disturbance and whether their combination can be used for early risk prediction.
The study is intended to characterize perioperative EEG features associated with postoperative sleep disturbance and to develop a clinically applicable risk prediction model. No study-specific treatment or intervention will be assigned to participants.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a prospective, single-center observational cohort study of adult patients undergoing elective gynecologic laparoscopic surgery. The study will examine perioperative changes in brain activity and their relationship with postoperative sleep disturbance.
Frontal EEG will be recorded during the perioperative period. Clinical information potentially related to postoperative sleep will also be collected, including baseline characteristics, preoperative sleep and psychological status, surgical and anesthetic information, and postoperative recovery variables. Sleep status and quality of recovery will be assessed after surgery using standardized questionnaires.
Patients will be classified according to postoperative sleep status. Perioperative EEG characteristics will be compared between patients with and without postoperative sleep disturbance. EEG features will then be analyzed together with clinical variables to identify factors associated with postoperative sleep disturbance and to develop a risk prediction model. The added predictive value of EEG information beyond clinical variables will also be evaluated.
The study does not alter routine anesthesia, surgery, or postoperative care. All clinical management will be determined by the treating clinical team.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Yinchuan, China
- General Hospital of Ningxia Medical University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adult female patients aged 18-80 years undergoing elective gynecologic laparoscopic surgery under general anesthesia at the General Hospital of Ningxia Medical University will be prospectively enrolled. Participants will receive routine perioperative care. Perioperative EEG and clinical data will be collected, and postoperative sleep and recovery will be assessed during the first two postoperative days.
Beschreibung
Inclusion Criteria:
- Female patients aged 18-80 years.
- Scheduled for elective gynecologic laparoscopic surgery under general anesthesia.
- Able to understand and complete the study questionnaires and assessments.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- History of severe neurological or psychiatric disorders that may affect EEG recordings or sleep assessment.
- Previously diagnosed severe sleep disorders requiring regular treatment.
- Long-term use of medications known to substantially affect sleep or central nervous system function.
- Severe cardiac, pulmonary, hepatic, or renal dysfunction.
- Preoperative conditions that prevent reliable EEG recording.
- Conversion to open surgery or other major changes in the planned surgical procedure.
- Inability to complete postoperative sleep or recovery assessments.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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Gynecologic Laparoscopic Surgery Cohort
Adult patients undergoing elective gynecologic laparoscopic surgery will be prospectively enrolled. Perioperative clinical information and frontal EEG data will be collected, and postoperative sleep and recovery will be assessed during the first two postoperative days. Participants will receive routine perioperative care without study-assigned interventions. |
Frontal EEG will be recorded during the perioperative period for analysis of brain activity associated with postoperative sleep disturbance. EEG monitoring will not be used to assign study-specific treatment or alter routine perioperative care. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Postoperative Sleep Disturbance
Zeitfenster: Postoperative days 1-2
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Postoperative sleep will be assessed using the Athens Insomnia Scale (AIS). The AIS consists of 8 items, with a total score ranging from 0 to 24; higher scores indicate more severe sleep disturbance. Postoperative sleep disturbance will be defined according to the prespecified AIS criterion in the study protocol. |
Postoperative days 1-2
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Postoperative Athens Insomnia Scale Score
Zeitfenster: Postoperative days 1 and 2
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The Athens Insomnia Scale (AIS) will be used to assess postoperative sleep. The scale consists of 8 items, with a total score ranging from 0 to 24. Higher scores indicate more severe sleep disturbance. |
Postoperative days 1 and 2
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Quality of Recovery-15 Score
Zeitfenster: Postoperative days 1 and 2
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Postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery. |
Postoperative days 1 and 2
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Frequency-specific Perioperative EEG Power Spectral Density
Zeitfenster: From the preoperative period through the end of anesthesia
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Frontal electroencephalography (EEG) recordings will be analyzed using spectral analysis to quantify frequency-specific EEG power spectral density (PSD) during prespecified perioperative periods. PSD will be calculated for prespecified frequency bands, including delta, theta, alpha, and beta bands, and expressed in μV²/Hz. Frequency-specific PSD values will be compared between participants with and without postoperative sleep disturbance, as defined by the prespecified Athens Insomnia Scale (AIS) criterion. |
From the preoperative period through the end of anesthesia
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Huiwen Zhang-2026-09
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