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Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery

18 de junio de 2026 actualizado por: Dong-Xin Wang, Peking University First Hospital

Intraoperative Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery: a Multicenter Randomized Trial

With aging population, more older patients will receive major surgery for cancer. Older patients are at increased risk of postoperative neurocognitive complications including delayed neurocognitive recovery (dNCR), which is associated with prolonged hospital stay, raised complications, and impaired quality of life. Intraoperative hypothermia occurs in 57.1%-78.6% of patients undergoing major cancer surgery, especially in the elderly. Studies show that intraoperative hypothermia suppresses immune function, interferes with anesthetic metabolism, and delays anesthesia emergence. All these may be correlated with the occurrence of early postoperative dNCR. This study aims to verify whether intraoperative targeted temperature management (target core temperature: 36.8°C) compared with conventional temperature management (core temperature: 35.5°C) can reduce the incidence of dNCR in older patients undergoing major cancer surgery.

Descripción general del estudio

Descripción detallada

With aging population, more older patients will undergo major surgery for cancer. Due to age-related cognitive decline, cancer-related frailty, as well as impacts from surgical trauma and anesthesia, older patients are at increased risk of postoperative neurocognitive complications including delayed neurocognitive recovery (dNCR), which refers to new-onset cognitive decline within 30 days after surgery. Studies reported that the incidence of dNCR within 7 days ranges from 23.2% to 41.4% in older patients after non-cardiac surgery. Patients with dNCR tend to have prolonged hospital stay, impaired quality of life, and even increased long-term cognitive disorders, and thus imposing a heavy burden on patients, their families, and the healthcare system.

The occurrence of dNCR after surgery results from the combined effects of predisposing factors (e.g., advanced age, preoperative cognitive impairment, comorbidities, malnutrition) and precipitating factors (e.g., anesthetic management, surgical stress, residual drug effects, postoperative complications). Among modifiable precipitating factors, unintended intraoperative hypothermia (core temperature <36 °C) is a common yet long underappreciated clinical issue. Due to prolonged operative duration, extensive body cavity exposure, and massive intraoperative fluid and blood transfusion, patients undergoing major cancer surgery have an incidence of intraoperative hypothermia between 57.1% and 78.6%.

Previous studies demonstrated that a core temperature below 35.5 °C is associated with multiple adverse events, including higher risks of intraoperative bleeding and blood transfusion and postoperative surgical site infections. The international multicenter randomized controlled PROTECT trial enrolled 5,056 patients over 45 years undergoing major non-cardiac surgery but found no significant differences in postoperative myocardial injury, surgical site infection, and blood loss between the routine management group (core temperature 35.5 °C) and the active warming group (core temperature 37 °C); these indicated that maintaining core temperature at 35.5 °C is safe with regard to these complications. However, neurocognitive function was not assessed in the PROTECT trial. Whether an intraoperative temperature of 35.5 °C is safe for the neurocognitive outcomes requires further investigation.

The pathogenesis of neurocognitive complications is complex, involving multiple pathological processes such as neuroinflammation, blood-brain barrier disruption, oxidative stress, and hippocampal neuronal injury. Perioperative hypothermia may trigger similar pathophysiological changes. Studies showed that hypothermia suppresses the immune function and promotes the release of peripheral pro-inflammatory cytokines including IL-6 and IL-1β, and thereby exacerbating central neuroinflammation, which is one of the core mechanisms underlying dNCR. Animal experiments demonstrated that hypothermia-induced cognitive dysfunction is associated with damage to hippocampal neurons and reduced expression of proteins related to synaptic plasticity. Furthermore, hypothermia impairs the metabolism of anesthetics and prolongs emergence time, which may contribute to the early manifestations of postoperative cognitive dysfunction.

There is still a lack of definitive evidence regarding whether intraoperative targeted temperature management can reduce dNCR in older patients undergoing major cancer surgery. Meanwhile, there remains debate over the hypothermia threshold and optimal target temperature range. We are currently conducting a multicenter randomized trial to verify whether intraoperative targeted temperature management (36.8 °C) reduces the incidence of delirium within 4 days in older patients after major cancer surgery. Based on patients enrolled at our institution, this study aims to verify whether intraoperative targeted temperature management (target core temperature: 36.8°C) compared with conventional temperature management (core temperature: 35.5°C) can reduce the incidence of delayed neurocognitive recovery in older patients undergoing major cancer surgery.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1512

Fase

  • No aplica

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100034
        • Peking University First Hospital
        • Contacto:
    • Guangdong
      • Shenzhen, Guangdong, Porcelana, 518036
        • Peking University Shenzhen Hospital
        • Contacto:

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

Sí

Descripción

Inclusion Criteria:

  1. Age ≥ 65 years.
  2. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.

Exclusion Criteria:

  1. Preoperative fever (tympanic temperature ≥ 38℃).
  2. Known or suspected preoperative infection.
  3. Previous schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or preexisting delirium.
  4. Inability to communicate due to coma, severe dementia, or hearing or speech impairment.
  5. Critically ill patients, defined as NYHA functional class > III or LVEF < 30%, Child-Pugh class C, preoperative dialysis dependence, ASA physical status > IV, or expected survival < 24 hours.
  6. Surgery for breast cancer, intracranial tumors, or rare cancers.
  7. Planned to undergo therapeutic hypothermia.
  8. Body mass index > 30 kg/m² (to facilitate temperature management).
  9. Previous enrollment in this study.
  10. Other conditions deemed unsuitable for study participation.

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

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Target temperature management
Pre-warming will be performed with a full-body forced-air cover and/or an electrically heated blanket for about 30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to about 43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. All intravenous fluids and blood products administered intraoperatively will be pre-warmed, and fluid/blood warming devices will be used as clinically indicated. Two forced-air warming blankets (or combined with an electric heating mattress) will be used to maintain core temperature. The goal is to maintain core temperature at 36.8°C.
Pre-warming will be performed with a full-body forced-air cover and/or an electrically heated blanket for about 30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to about 43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. All intravenous fluids and blood products administered intraoperatively will be pre-warmed, and fluid/blood warming devices will be used as clinically indicated. Two forced-air warming blankets (or combined with an electric heating mattress) will be used. The goal is to maintain the patient's core temperature at 36.8°C.
Otro: Routine thermal management
Pre-warming will not be performed before induction of anesthesia and ambient intraoperative temperature will be maintained near 20°C per routine. Only blood products will be pre-warmed before transfusion. One forced-air warming blanket will be placed over the patient's upper or lower body, but warming will only be initiated when the core temperature drops below 35.5°C to prevent further temperature reduction. The target core temperature is set at 35.5°C.
Pre-warming will not be performed before induction of anesthesia and ambient intraoperative temperature will be maintained near 20°C per routine. Only blood products will be pre-warmed before transfusion. One forced-air warming blanket will be placed over the patient's upper or lower body, but warming will only be initiated when the core temperature drops below 35.5°C to prevent further temperature reduction. The target core temperature is set at 35.5°C.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of delayed neurocognitive recovery (dNCR)
Periodo de tiempo: At 5 days after surgery or before hospital discharge, whichever came first

Cognitive function will be assessed at baseline and at 5 days after surgery (or before hospital discharge) using the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better cognitive function).

Delayed neurocognitive decline (dNCR) is defined as: a |Z| value of decline in MoCA score ≥1.96. Z value = [(change from baseline in MoCA score in a surgical patient - mean change from baseline in MoCA score in the non-surgical group)] / (standard deviation of change from baseline in MoCA score in the non-surgical group).

At 5 days after surgery or before hospital discharge, whichever came first

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of postoperative delirium
Periodo de tiempo: Up to 4 days after surgery
Delirium will be assessed twice daily (8-10 am and 6-8 pm) using the 3-Dimensional Confusion Assessment Method (3D-CAM) for patients without intubation or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for patients with intubation.
Up to 4 days after surgery
Incidence of postoperative neurocognitive disorder
Periodo de tiempo: At 30 days after surgery

Cognitive function will be assessed at baseline using MoCA (MoCA-22; scores range from 0 to 22, with higher scores indicating better cognitive function) and at 30 days after surgery using MoCA via telephone (T-MoCA; scores range from 0 to 22, with higher scores indicating better cognitive function).

Postoperative neurocognitive disorder (pNCD) is defined as: a |Z| value of decline in MoCA score ≥1.96. Z value = [(change from baseline in MoCA score in a surgical patient - mean change from baseline in MoCA score in the nonsurgical group)] / (standard deviation of change from baseline in MoCA score in the non-surgical group).

At 30 days after surgery

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Mortalidad a 30 días por todas las causas
Periodo de tiempo: Hasta 30 días después de la cirugía
Mortalidad a 30 días por todas las causas
Hasta 30 días después de la cirugía
Postoperative thermal discomfort
Periodo de tiempo: Up to 30 minutes after arriving PACU/ICU or after extubation

Postoperative thermal comfort will be evaluated with the Numerical Rating Scale (NRS; an 11-point scale where 0=intense cold, 5=thermal comfort, and 10=intense warm).

For patients who are extubated in the operation room, evaluation is conducted at 5 and 30 minutes after arriving post-anesthesia care unit (PACU)/intensive care unit (ICU). For patients who are admitted to PACU/ICU with endotracheal intubation, evaluation is conducted at 5 and 30 minutes after extubation. If patients remain intubated 2 hours after surgery, no further thermal comfort assessments will be conducted.

Up to 30 minutes after arriving PACU/ICU or after extubation
Postoperative shivering intensity
Periodo de tiempo: Up to 30 minutes after arriving PACU/ICU or after extubation

Postoperative shivering intensity is evaluated with a four-point scale (0=no shivering, 1=intermittent, mild shivering, 2=moderate shivering, and 3=persistent, intense shivering).

For patients who are extubated in the operation room, evaluation is conducted at 5 and 30 minutes after arriving post-anesthesia care unit (PACU)/intensive care unit (ICU). For patients who are admitted to PACU/ICU with endotracheal intubation, evaluation is conducted at 5 and 30 minutes after extubation. If patients remain intubated 2 hours after surgery, no further shivering assessments will be conducted.

Up to 30 minutes after arriving PACU/ICU or after extubation
Quality of recovery on postoperative day 1
Periodo de tiempo: At 24 hours after surgery
Quality of recovery will be assessed at 24 hours after surgery, using the 15-item quality of recovery scale (QoR-15; scores range from 0 to 150 points, with higher scores indicating better recovery).
At 24 hours after surgery
Units of blood transfused during and within 4 days of surgery
Periodo de tiempo: Up to 4 days after surgery
Units of blood transfused during surgery and the first 4 days after surgery.
Up to 4 days after surgery
Length of stay in post-anesthesia care unit (PACU)
Periodo de tiempo: Up to 24 hours after surgery
Length of stay in post-anesthesia care unit (PACU)
Up to 24 hours after surgery
Length of hospital stay after suregry
Periodo de tiempo: Up to 30 days after surgery
Length of hospital stay after surgery
Up to 30 days after surgery
Incidence of surgical site infections
Periodo de tiempo: Up to 30 days after surgery
Surgical site infections will include deep and organ-space infections, anastomotic leaks, wound dehiscence, abscess, and sepsis. The definitions were modified from "Guideline for prevention of surgical site infection, 1999" (https://stacks.cdc.gov/view/cdc/7160).
Up to 30 days after surgery
Incidence of other major complications
Periodo de tiempo: Up to 30 days after surgery
Other major complications are defined as new-onset condition that are deemed harmful and required therateutic intervention, i.e., class II or higher on the Clavien-Dindo classification.
Up to 30 days after surgery

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Dong-Xin U Wang, Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de octubre de 2028

Finalización del estudio (Estimado)

1 de noviembre de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de junio de 2026

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

18 de junio de 2026

Última verificación

1 de junio 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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