Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term 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
Peking University First Hospital
3,992 participants
May 29, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Age ≥65 years.
- Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.
Exclusion Criteria10
- 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.
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Interventions
Patients assigned to routine thermal management will not be pre-warmed and ambient intraoperative temperature will be maintained near 20°C per routine. Only transfused blood will be warmed. An upper- or lower-body forced-air cover will be positioned over an appropriate non-operative site but will not initially be activated. Should core temperature decrease to 35.5°C, the warmer will be activated as necessary to prevent core temperature from decreasing further. The target nasopharyngeal temperature is 35.5°C.
Pre-warming is performed with a full-body forced-air cover and electrically heated blanket for about 30 minutes before induction of anesthesia. The warmer will initially be set to "high" which corresponds to about 43°C. It will be subsequently adjusted to make patients feel warm, but not uncomfortably so. Patients will be warmed during surgery using two forced-air covers or combining forced-air covers with electric heating blanket when clinically practical. All intravenous fluids will be warmed to body temperature. There is no need to control ambient temperature since ambient temperature has little effect on core temperature in patients warmed with forced air. The target nasopharyngeal temperature is 36.8℃.
Locations(36)
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NCT06256354