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Perioperative EEG Prediction of Postoperative Sleep Disturbance in Gynecologic Laparoscopic Surgery

29 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Anmälan via inbjudan

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Yinchuan, Kina
        • General Hospital of Ningxia Medical University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Sleep Disturbance
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Athens Insomnia Scale Score
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 september 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

22 september 2026

Först inskickad som uppfyllde QC-kriterierna

29 september 2026

Första postat (Faktisk)

5 oktober 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 september 2026

Senast verifierad

1 september 2026

Mer information

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