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

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Age ≥65 years.

• Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.

Locations
Other Locations
China
Aerospace Medical Center
NOT_YET_RECRUITING
Beijing
Beijing Chuanyangliu Hospital
NOT_YET_RECRUITING
Beijing
Beijing Coal Group General Hospital
NOT_YET_RECRUITING
Beijing
Beijing Electric Power Hospital
NOT_YET_RECRUITING
Beijing
Dongzhimen Hospital Beijing University of Chinese Medicine
NOT_YET_RECRUITING
Beijing
Guang'anmen Hospital China Academy of Chinese Medical Sciences
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
The First Hospital of Tsinghua University
NOT_YET_RECRUITING
Beijing
Xiyuan Hospital of China Academy of Chinese Medical Sciences
RECRUITING
Beijing
Chengdu Seventh People's Hospital
RECRUITING
Chengdu
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Chengdu Medical College
RECRUITING
Chengdu
The Second People's Hospital of Yibin (affiliated with West China Hospital of Sichuan University)
NOT_YET_RECRUITING
Chengdu
The People's Hospital of Chizhou
NOT_YET_RECRUITING
Chizhou
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Deyang People's Hospital
NOT_YET_RECRUITING
Deyang
First Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
The Second Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Jiangyin People's Hospital
RECRUITING
Jiangyin
The First Affiliated Hospital Of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jingzhou
The First Affiliated Hospital of Kangda College of Nanjing Medical University ( Lianyungang First People's Hospital)
NOT_YET_RECRUITING
Lianyungang
The People's Hospital of Liaocheng
RECRUITING
Liaocheng
Maanshan People's Hospital
NOT_YET_RECRUITING
Ma’anshan
Jiangsu Province Hospital
RECRUITING
Nanjing
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
NOT_YET_RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
The People's Hospital of Wuxi
NOT_YET_RECRUITING
Wuxi
Xijing Hospital, Fourth Military Medical University
RECRUITING
Xi'an
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital Of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Dong-Xin Wang, MD, PhD
wangdongxin@hotmail.com
8610 83572784
Backup
Xin-quan Liang, MD
liangxinquan09@163.com
+8615210846532
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2032-06
Participants
Target number of participants: 3992
Treatments
Placebo_comparator: Routine thermal management
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.
Experimental: Target temperature management
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°C.
Related Therapeutic Areas
Sponsors
Leads: Peking University First Hospital
Collaborators: Peking University

This content was sourced from clinicaltrials.gov