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Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival

RecruitingNAAges 65 Years - anyAllPeking University First Hospital
NCT06256354 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Intraoperative hypothermia is common in patients having major surgery and the compliance with intraoperative temperature monitoring and management remains poor. Studies suggest that intraoperative hypothermia is an important risk factor of postoperative delirium, which is associated with worse early and long-term outcomes. Furthermore, perioperative hypothermia increases stress responses and provokes immune suppression, which might promote cancer recurrence and metastasis. In a recent trial, targeted temperature management reduced intraoperative hypothermia and emergence delirium. There was also a trend of reduced postoperative delirium, although not statistically significant. This trial is designed to test the hypothesis that intraoperative targeted temperature management may reduce postoperative delirium and improves progression-free survival in older patients recovering from major can

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📋 Eligibility rules (as published)
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 history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium. 4. Unable to communicate due to severe dementia, language barrier, or coma. 5. Critically ill (Left ventricular ejection fraction \<30%, Child-Pugh grades C, requirement of renal replacement therapy, American Society of Anesthesiologists physical status\>IV, or expected survival \<24 hours). 6. Scheduled surgery for breast cancer, intracranial tumors, or rare cancers. 7. Planned to undergo therapeutic hypothermia. 8. Body mass index \>30 kg/m2 (to facilitate thermal management). 9. Have participated in this study previously. 10. Any other conditions that are considered unsuitable for study participation.
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What it tests

  • Routine thermal management
  • Target temperature management
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Where

36 sites
The People's Hospital of Chizhou
Chizhou, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Maanshan People's Hospital
Ma’anshan, China
Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, China
Peking University First Hospital
Beijing, China
Guang'anmen Hospital China Academy of Chinese Medical Sciences
Beijing, China
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, China

…and 28 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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