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

Recruiting now · Not applicable

Conditions studied: Cancer Surgery, Intraoperative Hypothermia, Targeted Temperature Management, Postoperative Delirium, Long-term Survivors

In brief

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 cancer surgery.

Key facts

Study ID

NCT06256354

Run by

Peking University First Hospital

People needed

3992

Starts

2024-05-29

Expected to finish

2032-06-01

Last updated by the study team

2026-06-23

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Preoperative fever (tympanic temperature ≥38℃).
• Known or suspected preoperative infection.
• Previous history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium.
• Unable to communicate due to severe dementia, language barrier, or coma.
• 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).
• Scheduled surgery for breast cancer, intracranial tumors, or rare cancers.
• Planned to undergo therapeutic hypothermia.
• Body mass index >30 kg/m2 (to facilitate thermal management).
• Have participated in this study previously.
• Any other conditions that are considered unsuitable for study participation.

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
• Aerospace Medical Center — Beijing, Beijing Municipality, China (enrolling)
• Jiangyin People's Hospital — Jiangyin, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)
• Maanshan People's Hospital — Ma’anshan, Anhui, China (enrolling)
• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Xijing Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (enrolling)
• Beijing Electric Power Hospital — Beijing, Beijing Municipality, China (enrolling)
• The People's Hospital of Liaocheng — Liaocheng, Shandong, China (enrolling)
• Chengdu Seventh People's Hospital — Chengdu, Sichuan, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)
• The First Affiliated Hospital of Chengdu Medical College — Chengdu, Sichuan, China (enrolling)
• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
• Deyang People's Hospital — Deyang, Sichuan, China (enrolling)
• Guang'anmen Hospital China Academy of Chinese Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)
• Xiyuan Hospital of China Academy of Chinese Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital) — Shijiazhuang, Hebei, China
• Dongzhimen Hospital Beijing University of Chinese Medicine — Beijing, Beijing Municipality, China
• Beijing Chao-Yang Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Beijing Chuiyangliu Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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