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- Ensaio Clínico NCT07857174
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Yinchuan, China
- General Hospital of Ningxia Medical University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative Sleep Disturbance
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative Athens Insomnia Scale Score
Prazo: 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
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Quality of Recovery-15 Score
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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Outros números de identificação do estudo
- Huiwen Zhang-2026-09
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