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Preoperative Chronotype and Emergence Delirium in the Elderly

1 de agosto de 2026 actualizado por: Guangyou Duan, The Second Affiliated Hospital of Chongqing Medical University

An Observational Study on the Influence of Preoperative Sleep Time Types on Postoperative Delirium in Elderly Patients

Emergence delirium (ED) is a prevalent and severe postoperative complication in elderly surgical patients. It can occur at any perioperative stage but most frequently develops during or immediately after emergence from general anesthesia. Characterized by acute agitation and confusion, ED manifests as sharp declines in attention and cognitive function, accompanied by impaired consciousness and disorganized thinking. As a common adverse event in the early postoperative period, ED occurs in up to 87% of critically ill patients, 10%-24% of adult general medical patients, 37%-46% of anesthetized general surgical patients, with the highest incidence of 50% observed in elderly surgical patients during early recovery in the Post-Anesthesia Care Unit (PACU). Anesthesiologists have long attached great importance to the harmful effects of ED on clinical outcomes, as ED elevates risks of postoperative hemorrhage and physical trauma, extends PACU monitoring duration and hospital length of stay, and increases postoperative complications, mortality and medical resource consumption.

Chronotype describes the behavioral manifestation of the endogenous 24-hour circadian timing system. In mammals, circadian rhythms are maintained and regulated by a complete clock system: the central master clock resides in the suprachiasmatic nucleus (SCN) of the hypothalamus, while peripheral clocks exist in organs such as the liver, lungs and skeletal muscle. Patients with delirium commonly suffer severe circadian disturbances, which are embodied in disordered sleep-wake cycles, abnormal secretion rhythms of melatonin and cortisol, and altered expression of clock genes. Chronotypes are conventionally divided into morning, evening and intermediate types. Previous observational studies have proven that chronotype correlates with numerous disorders including metabolic diseases, psychiatric illnesses, brain function, delirium and cognitive performance. Accumulated evidence supports an association between delirium and circadian rhythms, and suggests that circadian dysfunction contributes to the pathological development of delirium.

Nevertheless, few studies have investigated how chronotype affects ED in elderly patients. This study intends to explore the correlation between chronotype and postoperative ED in elderly surgical patients and compare ED incidence among patients with distinct chronotypes. The results of this research will offer scientific references for formulating targeted preventive measures against ED in elderly populations, lower postoperative ED rates, alleviate adverse postoperative events, and optimize long-term clinical prognosis.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Actual)

235

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Porcelana, 400010
        • The Second Affiliated Hospital of Chongqing Medical University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

Researchers screened elderly inpatients scheduled to receive general anesthesia at The Second Affiliated Hospital of Chongqing Medical University from October 2024 to March 2025.

Descripción

Inclusion Criteria:

  1. Age of 65 years or older.
  2. Scheduled non-cardiac surgery under general anesthesia.
  3. American Society of Anesthesiologists (ASA) physical status I-III.
  4. Signed informed consent for surgical treatment.

Exclusion Criteria:

  1. Auditory or verbal impairment.
  2. Long-term use of psychotropic drugs or alcohol abuse.
  3. Pre-existing psychiatric disease or cognitive dysfunction.
  4. A medical history of cerebral infarction, dementia or hypoalbuminemia.

Withdrawal Criteria:

  1. Surgery duration less than 60 minutes
  2. Intraoperative blood transfusion
  3. Intraoperative hypothermia or hypotension
  4. Intraoperative administration of dexmedetomidine
  5. Postoperative transfer to intensive care unit
  6. Requirement for secondary surgical intervention

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
morning chronotype group
Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores ≥ 60
Emergence delirium was assessed at 30 minutes after admission to the post-anesthesia care unit (PACU) and at PACU discharge using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), a validated tool with high sensitivity and specificity for delirium detection.sment Method for the Intensive Care Unit (CAM-ICU)
non-morning chronotype group
Patients with the Morningness-Eveningness Questionnaire Self-Assessment Version (MEQ-SA) scores < 60
Emergence delirium was assessed at 30 minutes after admission to the post-anesthesia care unit (PACU) and at PACU discharge using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), a validated tool with high sensitivity and specificity for delirium detection.sment Method for the Intensive Care Unit (CAM-ICU)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of emergence delirium 1
Periodo de tiempo: At 30 minutes after post-anesthesia care unit admission
Use CAM-ICU
At 30 minutes after post-anesthesia care unit admission
Incidence of emergence delirium 2
Periodo de tiempo: Within 5 minutes prior to post-anesthesia care unit discharge.
Use CAM-ICU
Within 5 minutes prior to post-anesthesia care unit discharge.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative CAM-ICU scores 1
Periodo de tiempo: At 30 minutes after post-anesthesia care unit admission
Use CAM-ICU
At 30 minutes after post-anesthesia care unit admission
Postoperative CAM-ICU scores 2
Periodo de tiempo: Within 5 minutes prior to post-anesthesia care unit discharge.
Use CAM-ICU
Within 5 minutes prior to post-anesthesia care unit discharge.
Postoperative pain scores 1
Periodo de tiempo: At 30 minutes after post-anesthesia care unit admission
Use the visual analogue scale(VAS)
At 30 minutes after post-anesthesia care unit admission
Postoperative pain scores 2
Periodo de tiempo: Within 5 minutes prior to post-anesthesia care unit discharge.
Use the visual analogue scale(VAS)
Within 5 minutes prior to post-anesthesia care unit discharge.
Hospital length of stay
Periodo de tiempo: Up to 12 weeks
The period from when the patients enter the hospital until they leave the hospital
Up to 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de octubre de 2024

Finalización primaria (Actual)

26 de marzo de 2025

Finalización del estudio (Actual)

30 de marzo de 2025

Fechas de registro del estudio

Enviado por primera vez

15 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de julio de 2026

Publicado por primera vez (Actual)

23 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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