Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium … (NCT06256354) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival
China3,992 participantsStarted 2024-05-29
Plain-language summary
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.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Age ≥65 years.
✓. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of delirium within 4 days after surgery
Timeframe: During the first four days after surgery.
2
Progression-free survival after surgery [long-term]
Timeframe: Up to 3 years after surgery of the last enrolled patient.