Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06256354

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

Led by Peking University First Hospital · Updated on 2026-03-09

3992

Participants Needed

36

Research Sites

156 weeks

Total Duration

On this page

Sponsors

P

Peking University First Hospital

Lead Sponsor

P

Peking University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Older patients undergoing major cancer surgery often experience intraoperative hypothermia, which can increase the risk of postoperative delirium—a condition marked by sudden changes in attention and cognition—and may also affect long-term outcomes like cancer recurrence and survival. This study evaluates whether managing body temperature more precisely during surgery can reduce postoperative delirium and improve progression-free survival. The trial focuses on patients aged 65 and older undergoing potentially curative cancer surgeries lasting two hours or more under general anesthesia. Participants are randomly assigned to one of two temperature management approaches. The routine thermal management group will not receive pre-warming; ambient temperature is kept near 20°C, and warming devices activate only if core temperature drops below 35.5°C. The target temperature for this group is 35.5°C. The target temperature management group receives pre-warming with a full-body forced-air cover and heated blanket before anesthesia, with continuous warming during surgery to maintain a core temperature near 36.8°C. Intravenous fluids are also warmed in this group. Throughout the study, researchers will monitor delirium incidence within the first four days after surgery and track progression-free survival for up to three years. They will also assess patients’ thermal comfort, shivering intensity, emergence delirium, blood transfusion needs, and neurocognitive disorders at six months post-surgery. This comprehensive monitoring includes temperature measurements and clinical evaluations to understand the effects of temperature management on short- and long-term recovery and survival.

CONDITIONS

Brief Title

Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Planned potentially curative initial cancer surgery expected to last 2 hours or longer under general anesthesia
Not Eligible

You will not qualify if you...

  • Preoperative fever with tympanic temperature 38°C or higher
  • 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
  • Critically ill conditions such as left ventricular ejection fraction less than 30%, Child-Pugh grade C, requirement of renal replacement therapy, ASA physical status above IV, or expected survival less than 24 hours
  • Scheduled surgery for breast cancer, intracranial tumors, or rare cancers
  • Planned therapeutic hypothermia
  • Body mass index over 30 kg/m2
  • Previous participation in this study
  • Any other conditions considered unsuitable for study participation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day plus immediate intraoperative period

Participants undergo major cancer surgery with either routine thermal management or targeted temperature management during surgery to maintain core temperature and reduce complications.

1 intraoperative visit

Post-operative Follow-up

Duration - Up to 4 days after surgery

Participants are monitored for postoperative delirium, thermal comfort, shivering, emergence delirium, and blood transfusion needs during the initial days after surgery.

Daily visits for up to 4 days

Long-term Monitoring

Duration - Up to 3 years after surgery

Participants are followed to assess postoperative neurocognitive disorders and cancer-specific survival over several years after surgery.

Periodic visits up to 3 years

Trial Site Locations

Total: 36 locations

1

The People's Hospital of Chizhou

Chizhou, Anhui, China, 247099

Not Yet Recruiting

2

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230601

Actively Recruiting

3

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 610042

Actively Recruiting

4

Maanshan People's Hospital

Ma’anshan, Anhui, China

Actively Recruiting

5

Dongzhimen Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China, 100007

Not Yet Recruiting

6

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

7

Guang'anmen Hospital China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China, 100055

Actively Recruiting

8

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China, 100091

Actively Recruiting

9

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

10

Aerospace Medical Center

Beijing, Beijing Municipality, China

Actively Recruiting

11

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Not Yet Recruiting

12

Beijing Chuiyangliu Hospital

Beijing, Beijing Municipality, China

Not Yet Recruiting

13

Beijing Coal Group General Hospital

Beijing, Beijing Municipality, China

Not Yet Recruiting

14

Beijing Electric Power Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

15

Peking University International Hospital

Beijing, Beijing Municipality, China

Not Yet Recruiting

16

The First Hospital of Tsinghua University

Beijing, Beijing Municipality, China

Not Yet Recruiting

17

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Actively Recruiting

18

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China, 518034

Actively Recruiting

19

The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)

Shijiazhuang, Hebei, China, 050011

Not Yet Recruiting

20

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 163711

Actively Recruiting

21

The First Affiliated Hospital Of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

22

Henan Provincial People's Hospital

Zhengzhou, Henan, China, 463599

Not Yet Recruiting

23

Jingzhou Central Hospital

Jingzhou, Hubei, China

Not Yet Recruiting

24

Jiangyin People's Hospital

Jiangyin, Jiangsu, China, 214400

Actively Recruiting

25

The First Affiliated Hospital of Kangda College of Nanjing Medical University ( Lianyungang First People's Hospital)

Lianyungang, Jiangsu, China

Not Yet Recruiting

26

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

27

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Not Yet Recruiting

28

The People's Hospital of Wuxi

Wuxi, Jiangsu, China, 214023

Not Yet Recruiting

29

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China, 710032

Actively Recruiting

30

The First Affiliated Hospital Of Shandong First Medical University

Jinan, Shandong, China, 250013

Not Yet Recruiting

31

The People's Hospital of Liaocheng

Liaocheng, Shandong, China, 252000

Actively Recruiting

32

Chengdu Seventh People's Hospital

Chengdu, Sichuan, China, 610041

Actively Recruiting

33

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China, 610072

Actively Recruiting

34

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China, 610500

Actively Recruiting

35

The Second People's Hospital of Yibin (affiliated with West China Hospital of Sichuan University)

Chengdu, Sichuan, China

Not Yet Recruiting

36

Deyang People's Hospital

Deyang, Sichuan, China

Actively Recruiting

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Research Team

D

Dong-Xin Wang, MD, PhD

X

Xin-quan Liang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Guidelines of the Polish Society of Anaesthesiology and Intensive Therapy regarding prevention of inadvertent intraoperative hypothermia.

Bartosz Horosz, Artur Adamiec, Małgorzata Malec-Milewska...

https://pubmed.ncbi.nlm.nih.gov/35100795

Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air.

Zhuo Sun, Hooman Honar, Daniel I Sessler...

https://pubmed.ncbi.nlm.nih.gov/25603202

Aggressive intraoperative warming versus routine thermal management during non-cardiac surgery (PROTECT): a multicentre, parallel group, superiority trial.

Daniel I Sessler, Lijian Pei, Kai Li...

https://pubmed.ncbi.nlm.nih.gov/35390321

Estimates of Geriatric Delirium Frequency in Noncardiac Surgeries and Its Evaluation Across the Years: A Systematic Review and Meta-analysis.

Ana Rita Silva, Patrícia Regueira, Elisabete Albuquerque...

https://pubmed.ncbi.nlm.nih.gov/33011097