Managing body temperature during cancer surgery to reduce delirium and improve survival

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of intraoperative targeted temperature management on the incidence of postoperative delirium and long-term survival in older patients undergoing major cancer surgery. It aims to address the common issue of perioperative hypothermia, which can lead to complications such as delirium and increased cancer recurrence. The study will compare routine thermal management with targeted temperature management to determine its effectiveness in improving patient outcomes. By monitoring and managing body temperature during surgery, the trial seeks to enhance recovery and reduce adverse effects associated with hypothermia.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Maanshan People's Hospital
  Ma’anshan, Anhui, China Recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Guang'anmen Hospital China Academy of Chinese Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Xiyuan Hospital of China Academy of Chinese Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD
• Email: wangdongxin@hotmail.com
• Phone: 8610 83572784

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.