Clinical trial NCT06256354: Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypothermia
Delirium
Long-term Survivors
Cancer Surgery
Keywords: Hypothermia
Delirium
Cancer surgery
Long-term survival
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2024-02-13
Enrollment: 3992
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Perioperative hypothermia results from anesthetic-impaired thermoregulatory responses combined with cool operating rooms and exposed body cavities. Core temperatures \<35.5°C increases perioperative blood loss, delays post anesthetic recovery, and increases surgical wound infections.

Despite guideline recommendations, compliance with intraoperative temperature monitoring and management remains poor. In a national survey published in 2017, intraoperative hypothermia (core temperature \<36.0°C) occurred in 44% of patients having elective surgery with general anesthesia. According to a survey of anesthesiologists in six Asia-Pacific countries (Singapore, Malaysia, Philippines, Thailand, India, and South Korea), only 67% of respondents measured temperature intraoperatively during general anesthesia, and only 44% report intraoperative active warming and warming was ineffective in more than half of their patients. Perioperative hypothermia thus remains common.

The 5,056-patient PROTECT trial showed that myocardial injury, surgical site infections, and blood loss were similar in patients randomized to intraoperative core temperatures of 35.5 or 37°C. However, there are other important complications that may be caused by intraoperative hypothermia including delirium, cancer recurrence, shivering, and thermal discomfort.

Perioperative neurocognitive disorders (NCDs), especially postoperative delirium and postoperative cognitive dysfunction (POCD), are significant challenges to older patients scheduled for surgery. Delirium is a syndrome of acutely occurring and fluctuating changes in attention, level of consciousness, and cognitive function. Postoperative cognitive dysfunction refers to cognitive decline (including the ability of study, memory, action, and judgement) detected from 30 days to 12 months after surgery.

In patients aged 60 years or above, the incidence of postoperative delirium is about 12-24%. The incidence of POCD is about 7-12% at 3-month follow-up and is associated with delirium, although the relationship is probably not causal. Delirium and POCD are associated with worse perioperative outcomes including prolonged hospitalization, increased complications, and high mortality, and worse long-term outcomes including shortened overall survival, as well as increased dementia and lowered life quality.

Postoperative delirium and POCD are multifactorial. Predisposing factors include advanced age, lower educational level, cognitive impairment, comorbidities (e.g., cerebrovascular disease, diabetes, and kidney disease), alcohol abuse, and malnutrition. Precipitating factors include deep anesthesia, opioid use, benzodiazepines, intraoperative blood loss/blood transfusion, and severe pain. Hypothermia may also increase the risk of delirium.

Hypothermia provokes both autonomic and behavioral protective responses. The first autonomic response is arterio-venous shunt constriction. Thermoregulatory vasoconstriction occurs many times a day in a typical hospital environment. It is highly effective, but does not usually disturb people and is generally considered to be of little consequence. Shivering is the other primary autonomic thermoregulatory defense against cold and has a triggering threshold about 1°C below the core temperature that triggers vasoconstriction. Unlike vasoconstriction, shivering is uncomfortable for patients. Furthermore, it is accompanied by a tripling of catecholamine concentrations, hypertension, and tachycardia. Behavioral thermoregulatory defenses are mediated by thermal comfort, and provoke voluntary defensive measures such as putting on a sweater, open windows, etc. Behavioral defenses include air conditioning and building shelters and are thus far stronger than autonomic responses. Thermal comfort matters to patients and is thus worth evaluating.

Despite advances in surgery and oncology, postoperative survival decreases about 10% per year, mainly due to cancer recurrence. The development of cancer recurrence mainly depends on the balance between the invasive ability of residual cancer cells and the anti-cancer immune function. Perioperative hypothermia increases stress responses and provokes immune suppression.

The investigators therefore propose to determine whether intraoperative targeted temperature management decreases the incidence of delirium, improves thermal comfort, reduces postoperative shivering, and improves long-term survival in older patients recovering from major cancer surgery. Specifically, the investigators will test the primary short-term hypothesis that perioperative normothermia (core temperature near 36.8°C) reduces delirium over the initial 4 postoperative days. Secondary short-term hypotheses are that perioperative normothermia improves thermal comfort, reduces shivering, and reduces delayed neurocognitive recovery. The primary long-term hypothesis is that perioperative normothermia improves progression-free survival.

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 history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium.
4. Unable to communicate due to severe dementia, language barrier, or coma.
5. 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).
6. Scheduled surgery for breast cancer, intracranial tumors, or rare cancers.
7. Planned to undergo therapeutic hypothermia.
8. Body mass index \>30 kg/m2.
9. Have participated in this study previously.
10. Any other conditions that are considered unsuitable for study participation.

Primary outcomes:
measure: Incidence of delirium within 4 days after surgery
timeFrame: During the first four days after surgery.
measure: Progression-free survival after surgery
timeFrame: Up to 2 years after surgery of the last enrolled patient.
Secondary outcomes:
measure: Postoperative thermal comfort
timeFrame: Up to 30 minutes after arriving PACU/ICU or after extubation.
measure: Postoperative shivering intensity
timeFrame: Up to 30 minutes after arriving PACU/ICU or after extubation.
measure: Incidence of delayed neurocognitive recovery
timeFrame: At 30 days after surgery.
measure: Incidence of postoperative neurocognitive disorders
timeFrame: At 6 months and 12 months after surgery.
Other outcomes:
measure: Incidence of emergence delirium
timeFrame: Up to 30 minutes after arriving PACU/ICU or after extubation.
measure: Length of stay in post-anesthesia care unit (PACU)
timeFrame: Up to 24 hours after surgery.
measure: Change of blood hemoglobin in the first postoperative day
timeFrame: Up to 24 hours after surgery.
measure: Quality of recovery in the first postoperative day
timeFrame: Up to 24 hours after surgery.
measure: Proportion of patients requiring blood transfusion
timeFrame: Up to 4 days after surgery.
measure: Length of stay in hospital after surgery
timeFrame: Up to 30 days after surgery.
measure: Incidence of surgical site infections with 30 days after surgery
timeFrame: Up to 30 days after surgery.
measure: Incidence of non-delirium major complications within 30 days after surgery.
timeFrame: Up to 30 days after surgery
measure: All-cause 30-day mortality
timeFrame: Up to 30 days after surgery.
measure: Overall survival after surgery
timeFrame: Up to 2 years after surgery of the last enrolled patient.
measure: Cancer-specific survival after surgery
timeFrame: Up to 2 years after surgery of the last enrolled patient.
measure: Event-free survival after surgery
timeFrame: Up to 2 years after surgery of the last enrolled patient.
Locations:
city: Chizhou
country: China
facility: The Pepple's Hospital of Chizhou
state: Anhui
city: Beijing
country: China
facility: Dongzhimen Hospital Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital of CACMS（China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shijia Zhuang
country: China
facility: The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital Of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Jiangyin
country: China
facility: Jiangyin People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Wuxi
country: China
facility: The People's Hospital of Wuxi
state: Jiangsu
city: Jinan
country: China
facility: The First Affiliated Hospital Of Shandong First Medical University
state: Shandong
city: Liaocheng
country: China
facility: The Pepple's Hospital of Liaocheng
state: Shandong
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shanxi
city: Chendu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chendu
country: China
facility: The First Affiliated Hospital of Chengdu Medical College
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Seventh People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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