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

2026년 6월 18일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

1512

단계

  • 해당 없음

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연구 연락처

연구 연락처 백업

연구 장소

    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100034
        • Peking University First Hospital
        • 연락하다:
    • Guangdong
      • Shenzhen, Guangdong, 중국, 518036
        • Peking University Shenzhen Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of delayed neurocognitive recovery (dNCR)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Incidence of postoperative delirium
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
모든 원인 30일 사망
기간: 수술 후 30일까지
모든 원인 30일 사망
수술 후 30일까지
Postoperative thermal discomfort
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: Up to 30 days after surgery
Length of hospital stay after surgery
Up to 30 days after surgery
Incidence of surgical site infections
기간: 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
기간: 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

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수사관

  • 수석 연구원: Dong-Xin U Wang, Dong-Xin Wang, MD, PhD, Peking University First Hospital

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 10월 1일

연구 완료 (추정된)

2028년 11월 1일

연구 등록 날짜

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2026년 6월 13일

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2026년 6월 23일

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