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.
Age ≥65 years.
Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.
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.
Parallel
Routine thermal management
Other interventionPatients 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.
Target temperature management
Other interventionPre-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℃.
Incidence of delirium within 4 days after surgery
Occurrence of delirium during the first four postoperative days is assessed with the 3D-Confusion Assessment Method (3D-CAM) or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU; for intubated patients) twice daily (8-10 am and 6-8 pm). Any positive CAM evaluation will be considered evidence of delirium. Immediately before assessing delirium, sedation or agitation is assessed with the Richmond Agitation-Sedation Scale (RASS; scores range from -5 \[unarousable\] to +4 \[combative\] and 0 indicates alert and calm). Deeply sedated or unarousable patients (RASS -4 or -5) is recorded as comatose and not assessed for delirium.
Postoperative thermal comfort
Postoperative thermal comfort is evaluated with the Numerical Rating Scale (NRS; an 11-point scale where 0=intense cold, 5=thermal comfort, and 10=intense warm). For patients who are extubated in the operation room, evaluation is conducted at 5 and 30 minutes after arriving post-anesthesia care unit (PACU)/intensive care unit (ICU). For patients who are admitted to PACU/ICU with endotracheal intubation, evaluation is conducted at 5 and 30 minutes after extubation. If patients remain intubated 2 hours after surgery, no further thermal comfort assessments will be conducted.
Postoperative shivering intensity
Postoperative shivering intensity is evaluated with a four-point scale (0=no shivering, 1=intermittent, mild shivering, 2=moderate shivering, and 3=persistent, intense shivering). For patients who are extubated in the operation room, evaluation is conducted at 5 and 30 minutes after arriving post-anesthesia care unit (PACU)/intensive care unit (ICU). For patients who are admitted to PACU/ICU with endotracheal intubation, evaluation is conducted at 5 and 30 minutes after extubation. If patients remain intubated 2 hours after surgery, no further shivering assessments will be conducted.
Incidence of emergence delirium
Patients are firstly be evaluated with the Richmond Agitation-Sedation Scale (RASS; scores range from -5 \[unarousable\] to +4 \[combative\] and 0 indicates alert and calm). Patients will then be evaluated with the Confusion Assessment Method (CAM-ICU) for the Intensive Care Unit. For patients who are extubated in the operation room, evaluation is conducted at 5 and 30 minutes after arriving post-anesthesia care unit (PACU)/intensive care unit (ICU). For patients who are admitted to PACU/ICU with endotracheal intubation, evaluation is conducted at 5 and 30 minutes after extubation. If patients remain intubated 2 hours after surgery, no further emergence delirium assessments will be conducted.
Units of blood transfused during and within 4 days of surgery
Units of blood transfused during surgery and the first 4 days after surgery.
Length of stay in post-anesthesia care unit (PACU)
Length of stay in post-anesthesia care unit (PACU)
Quality of Recovery-15 score on the first day after surgery
Quality of recovery is assessed with the Quality of Recovery-15 questionaire in the first postoperative day.
Change in hemoglobin from baseline (last preoperative concentration) to the lowest concentration on the first day after surgery
Change in hemoglobin from baseline (last preoperative concentration) to the lowest concentration on the first day after surgery
Postoperative duration of hospitalization
Postoperative duration of hospitalization
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Peking University First Hospital
Lead sponsor
Peking University
Collaborator
