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

Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival in Older Patients Having Major Cancer Surgery: A Multicenter Randomized Trial

Not applicable Interventional Peking University First Hospital · NCT06256354

This study tests if keeping older patients at a specific body temperature during major cancer surgery can help reduce confusion after surgery and improve their chances of survival.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment3992 (estimated)
Ages65 Years and up
SexAll
SponsorPeking University First Hospital Academic / other
Locations36 sites (Chizhou, Anhui and 35 other locations)
Trial IDNCT06256354 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 65 years and older who are scheduled for potentially curative cancer surgery lasting two hours or more under general anesthesia.

Not a fit: Patients with preoperative infections, severe comorbidities, or those undergoing specific types of cancer surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium and improve long-term survival rates for older cancer surgery patients.

How similar studies have performed: Previous studies have shown promising results with targeted temperature management, although this specific approach in the context of cancer surgery is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chizhou, Anhui and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cancer SurgeryHypothermiaDeliriumLong-term SurvivorsCancer surgeryLong-term survival
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.