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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Yinchuan, Chiny
- General Hospital of Ningxia Medical University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Sleep Disturbance
Ramy czasowe: Postoperative days 1-2
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative Athens Insomnia Scale Score
Ramy czasowe: Postoperative days 1 and 2
|
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
|
|
Quality of Recovery-15 Score
Ramy czasowe: Postoperative days 1 and 2
|
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
|
|
Frequency-specific Perioperative EEG Power Spectral Density
Ramy czasowe: From the preoperative period through the end of anesthesia
|
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
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Huiwen Zhang-2026-09
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .