Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Target temperature management: Pre-warming will be performed with a full-body forced-air cover and/or an 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. All intravenous fluids and blood products administered intraoperatively will be pre-warmed, and fluid/blood warming devices will be used as clinically indicated. Two forced-air warming blankets (or combined with an electric heating mattress) will be used. The goal is to maintain the patient's core temperature at 36.8°C.

Routine thermal management: Pre-warming will not be performed before induction of anesthesia and ambient intraoperative temperature will be maintained near 20°C per routine. Only blood products will be pre-warmed before transfusion. One forced-air warming blanket will be placed over the patient's upper or lower body, but warming will only be initiated when the core temperature drops below 35.5°C to prevent further temperature reduction. The target core temperature is set at 35.5°C.

Study 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 immune function, 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

Primary outcome measure(s)

• Incidence of delayed neurocognitive recovery (dNCR) — At 5 days after surgery or before hospital discharge, whichever came first
  Cognitive function will be assessed at baseline and at 5 days after surgery (or before hospital discharge) using the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better cognitive function). Delayed neurocognitive decline (dNCR) is defined as: a \|Z\| value of decline in MoCA score ≥1.96. Z value = \[(change from baseline in MoCA score in a surgical patient - mean change from baseline in MoCA score in the non-surgical group)\] / (standard deviation of change from baseline in MoCA score in the non-surgical group).

Trial sites (2)

More Peking University First Hospital trials in China

Other trials for the same condition