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NCT07655687
Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery
Conditions: Elderly Patients, Cancer Surgery, Hypothermia, Accidental, Targeted Temperature Management, Delayed Neurocognitive Recovery
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 1512
Sponsor: Peking University First Hospital
Location: Peking University First Hospital Beijing Beijing Municipality
Summary
With aging population, more older patients will receive major surgery for cancer. Older patients are at increased risk of postoperative neurocognitive complications including delayed neurocognitive recovery (dNCR), which is associated with prolonged hospital stay, raised complications, and impaired quality of life. Intraoperative hypothermia occurs in 57.1%-78.6% of patients undergoing major cancer surgery, especially in the elderly. Studies show that intraoperative hypothermia suppresses immunity, interferes with anesthetic metabolism, and delays anesthesia emergence. All these may be correlated with the occurrence of early postoperative dNCR. This study aims to verify whether intraoperative targeted temperature management (target core temperature: 36.8°C) compared with conventional temperature management (core temperature: 35.5°C) can reduce the incidence of dNCR in older patients undergoing major cancer surgery.
Eligibility 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 schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or preexisting delirium.
4. Inability to communicate due to coma, severe dementia, or hearing or speech impairment.
5. Critically ill patients, defined as NYHA functional class \> III or LVEF \< 30%, Child-Pugh class C, preoperative dialysis dependence, ASA physical status \> IV, or expected survival \< 24 hours.
6. Surgery for breast cancer, intracranial tumors, or rare cancers.
7. Planned to undergo therapeutic hypothermia.
8. Body mass index \> 30 kg/m² (to facilitate temperature management).
9. Previous enrollment in this study.
10. Other conditions deemed unsuitable for study participation.
Source: ClinicalTrials.gov (NCT07655687). StuddyBuddy aggregates publicly available trial information.