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Perioperative EEG Prediction of Postoperative Sleep Disturbance in Gynecologic Laparoscopic Surgery

29. september 2026 opdateret af: General Hospital of Ningxia Medical University

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.

Studieoversigt

Status

Tilmelding efter invitation

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Yinchuan, Kina
        • General Hospital of Ningxia Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Sleep Disturbance
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Athens Insomnia Scale Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

22. september 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

22. september 2026

Først indsendt, der opfyldte QC-kriterier

29. september 2026

Først opslået (Faktiske)

5. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

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