About this trial

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.

Eligibility criteria

Qualifiers

Age ≥65 years.

Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Routine thermal management
  • Target temperature management

Treatment groups

3,992 Participants
are divided into 2 treatment groups

Locations

36
The People's Hospital of Chizhou247099, ChizhouAnhui, China
The First Affiliated Hospital of Anhui Medical University610042, HefeiAnhui, China
The Second Affiliated Hospital of Anhui Medical University230601, HefeiAnhui, China
Maanshan People's Hospital Ma’anshanAnhui, China

Sponsors and collaborators

Peking University First Hospital

Lead sponsor

Peking University

Collaborator