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Cancer SurgeryNCT06256354

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

A study testing Routine thermal management and Target temperature management in people with Cancer Surgery and Intraoperative Hypothermia, run by Peking University First Hospital at 36 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Routine thermal management and Target temperature management
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,992 participants
Where
36 sitesChina
Study dates
29 May 2024to Jun 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥65 years.
  • Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.

Who cannot join

  • 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.
  • 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).
  • Scheduled surgery for breast cancer, intracranial tumors, or rare cancers.
Show all 10Show fewer
  • Planned to undergo therapeutic hypothermia.
  • Body mass index >30 kg/m2 (to facilitate thermal management).
  • Have participated in this study previously.
  • Any other conditions that are considered unsuitable for study participation.

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dong-Xin Wang, MD, PhD contact

8610 83572784

wangdongxin@hotmail.com

Xin-quan Liang, MD contact

+8615210846532

liangxinquan09@163.com

36 sites in 1 country

China36 sites, 36 recruiting

  • Dongzhimen Hospital Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100007

    Guo-kai Liu, 8610-80816655, liuguokaidoc@163.com

    Not yet recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Xin-Quan Liang, MD, +86 15210846532, xq_liang@foxmail.com

    Recruiting

  • Guang'anmen Hospital China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality, 100055

    Xi-chen Dong, +86 13810248772

    Recruiting

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality, 100091

    Xiu-mei Gao, +86 13810208575, 2592153818@qq.com

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Li-jian Pei, 8610-65296114, hazelbeijing@vip.163.com

    Recruiting

  • Aerospace Medical Center

    Beijing, Beijing Municipality

    Zhanmin Yang, 86 18610197799

    Recruiting

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Changwei Wei, M.D., 86 13810678936

    Not yet recruiting

  • Beijing Chuiyangliu Hospital

    Beijing, Beijing Municipality

    Yanwei Yang, 86 18612596817

    Not yet recruiting

  • Beijing Coal Group General Hospital

    Beijing, Beijing Municipality

    Yonggang Li, 86 13241867130

    Not yet recruiting

  • Beijing Electric Power Hospital

    Beijing, Beijing Municipality

    Wenyong Han, 86 13671003131

    Recruiting

  • Peking University International Hospital

    Beijing, Beijing Municipality

    Kunpeng Liu, M.D., +8613681446866

    Not yet recruiting

  • The First Hospital of Tsinghua University

    Beijing, Beijing Municipality

    Duomao Lin, 86 13811495413

    Not yet recruiting

  • Chengdu Seventh People's Hospital

    Chengdu, Sichuan, 610041

    Hui Zhong, +86 18280318565, qyymzsszx@163.com

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Qian Lei, +86 17744339891, leiqianggh@163.com

    Recruiting

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan, 610500

    Ping-liang Yang, +86 18140064602, pingliangyang@163.com

    Recruiting

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

    Chengdu, Sichuan

    Jinghua Ren, M.D., 8613568084991

    Not yet recruiting

  • The People's Hospital of Chizhou

    Chizhou, Anhui, 247099

    Ming-sheng Bao, +86 15339668345

    Not yet recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Su Min, +86 13508302749, ms89011068@163.com

    Recruiting

  • Deyang People's Hospital

    Deyang, Sichuan

    Xianjie Zhang, M.D., 86 13981088319

    Recruiting

  • First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 163711

    Kun Wang, MD, hydwangkun@sina.com

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Ye Zhang, MD, zhangye_hassan@sina.com

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 610042

    Xuesheng Liu, +86 18655193385

    Recruiting

  • Jiangyin People's Hospital

    Jiangyin, Jiangsu, 214400

    Jian-qing Chen, +86 18921233188

    Recruiting

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong, 250013

    Jian-bo Wu, +86 13805319310, jianbowu@sdu.edu.cn

    Not yet recruiting

  • Jingzhou Central Hospital

    Jingzhou, Hubei

    Kun Zhang, 86 18107168484

    Not yet recruiting

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

    Lianyungang, Jiangsu

    Yong Wu, 86 18961325621

    Not yet recruiting

  • The People's Hospital of Liaocheng

    Liaocheng, Shandong, 252000

    Chong-wang Zhang, +86 13346256809, zwzhang68@sina.com

    Recruiting

  • Maanshan People's Hospital

    Ma’anshan, Anhui

    Jun Jing, 86 13965378174

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Cun-ming Liu, +86 13951890866, cunmingliu@njmu.edu.cn

    Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518034

    Tao Luo, +86 13510820779, 496855048@qq.com

    Recruiting

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

    Shijiazhuang, Hebei, 050011

    Chao Li, jysylc@163.com

    Not yet recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Jiang Zhu, 86 13962153438

    Not yet recruiting

  • The People's Hospital of Wuxi

    Wuxi, Jiangsu, 214023

    Xin Zhang, +86 13818832760, xinzhang3@njmu.edu.cn

    Not yet recruiting

  • Xijing Hospital, Fourth Military Medical University

    Xi'an, Shaanxi, 710032

    Zhi-Hong Lu, MD, +86 13891975018, deerlu23@163.com

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Jian-Jun Yang, +86 13357739238, yjyangjj@126.com

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 463599

    Jia-qiang Yang, +86 13937121360

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the 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, reduces incidence of emergence delirium, and reduces blood transfusion. The primary long-term hypothesis is that perioperative normothermia improves progression-free survival.

Being tested
Routine thermal management, Target temperature management
Keywords
Cancer surgery, Intraoperative hypothermia, Targeted temperature management, Postoperative delirium, Long-term survival
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine thermal managementOther

    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.

  • Target temperature managementOther

    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℃.

Study groups in NCT06256354
Study groupRoleWhat they receive
Routine thermal managementPlacebo comparatorPatients 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.
Receives: Other: Routine thermal management
Target temperature managementExperimentalPre-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.
Receives: Other: Target temperature management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the first four days after surgery.

Secondary outcomes (4)

  1. 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.

    Measured: Up to 30 minutes after arriving PACU/ICU or after extubation.

  2. 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.

    Measured: Up to 30 minutes after arriving PACU/ICU or after extubation.

  3. 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.

    Measured: Up to 30 minutes after arriving PACU/ICU or after extubation.

  4. Units of blood transfused during and within 4 days of surgery

    Units of blood transfused during surgery and the first 4 days after surgery.

    Measured: Up to 4 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start29 May 2024
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,992 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06256354
Sponsor's protocol ID
2024-185
Status last verified
Jun 2026
First submitted
5 Feb 2024
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Horosz B, Adamiec A, Malec-Milewska M, Misiolek H. Guidelines of the Polish Society of Anaesthesiology and Intensive Therapy regarding prevention of inadvertent intraoperative hypothermia. Anaesthesiol Intensive Ther. 2021;53(5):376-385. doi: 10.5114/ait.2021.111871.

    PubMed 35100795

  • Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.

    PubMed 18156884

  • Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.

    PubMed 19137808

  • Yi J, Lei Y, Xu S, Si Y, Li S, Xia Z, Shi Y, Gu X, Yu J, Xu G, Gu E, Yu Y, Chen Y, Jia H, Wang Y, Wang X, Chai X, Jin X, Chen J, Xu M, Xiong J, Wang G, Lu K, Yu W, Lei W, Qin Z, Xiang J, Li L, Xiang Z, Pan S, Zhan L, Qiu K, Yao M, Huang Y. Intraoperative hypothermia and its clinical outcomes in patients undergoing general anesthesia: National study in China. PLoS One. 2017 Jun 8;12(6):e0177221. doi: 10.1371/journal.pone.0177221. eCollection 2017.

    PubMed 28594825

  • Koh W, Chakravarthy M, Simon E, Rasiah R, Charuluxananan S, Kim TY, Chew STH, Brauer A, Ti LK. Perioperative temperature management: a survey of 6 Asia-Pacific countries. BMC Anesthesiol. 2021 Aug 16;21(1):205. doi: 10.1186/s12871-021-01414-6.

    PubMed 34399681

  • Sun Z, Honar H, Sessler DI, Dalton JE, Yang D, Panjasawatwong K, Deroee AF, Salmasi V, Saager L, Kurz A. Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air. Anesthesiology. 2015 Feb;122(2):276-85. doi: 10.1097/ALN.0000000000000551.

    PubMed 25603202

  • Sessler DI, Pei L, Li K, Cui S, Chan MTV, Huang Y, Wu J, He X, Bajracharya GR, Rivas E, Lam CKM; PROTECT Investigators. Aggressive intraoperative warming versus routine thermal management during non-cardiac surgery (PROTECT): a multicentre, parallel group, superiority trial. Lancet. 2022 May 7;399(10337):1799-1808. doi: 10.1016/S0140-6736(22)00560-8. Epub 2022 Apr 4.

    PubMed 35390321

  • Kong H, Xu LM, Wang DX. Perioperative neurocognitive disorders: A narrative review focusing on diagnosis, prevention, and treatment. CNS Neurosci Ther. 2022 Aug;28(8):1147-1167. doi: 10.1111/cns.13873. Epub 2022 Jun 1.

    PubMed 35652170

  • Silva AR, Regueira P, Albuquerque E, Baldeiras I, Cardoso AL, Santana I, Cerejeira J. Estimates of Geriatric Delirium Frequency in Noncardiac Surgeries and Its Evaluation Across the Years: A Systematic Review and Meta-analysis. J Am Med Dir Assoc. 2021 Mar;22(3):613-620.e9. doi: 10.1016/j.jamda.2020.08.017. Epub 2020 Oct 1.

    PubMed 33011097

  • Berian JR, Zhou L, Russell MM, Hornor MA, Cohen ME, Finlayson E, Ko CY, Rosenthal RA, Robinson TN. Postoperative Delirium as a Target for Surgical Quality Improvement. Ann Surg. 2018 Jul;268(1):93-99. doi: 10.1097/SLA.0000000000002436.

    PubMed 28742701

  • Goldberg TE, Chen C, Wang Y, Jung E, Swanson A, Ing C, Garcia PS, Whittington RA, Moitra V. Association of Delirium With Long-term Cognitive Decline: A Meta-analysis. JAMA Neurol. 2020 Nov 1;77(11):1373-1381. doi: 10.1001/jamaneurol.2020.2273.

    PubMed 32658246

  • Huang H, Li H, Zhang X, Shi G, Xu M, Ru X, Chen Y, Patel MB, Ely EW, Lin S, Zhang G, Zhou J. Association of postoperative delirium with cognitive outcomes: A meta-analysis. J Clin Anesth. 2021 Dec;75:110496. doi: 10.1016/j.jclinane.2021.110496. Epub 2021 Sep 2.

    PubMed 34482263

  • Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.

    PubMed 20664045

  • Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of Delirium and Other Major Complications on Outcomes After Elective Surgery in Older Adults. JAMA Surg. 2015 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606.

    PubMed 26352694

  • Crocker E, Beggs T, Hassan A, Denault A, Lamarche Y, Bagshaw S, Elmi-Sarabi M, Hiebert B, Macdonald K, Giles-Smith L, Tangri N, Arora RC. Long-Term Effects of Postoperative Delirium in Patients Undergoing Cardiac Operation: A Systematic Review. Ann Thorac Surg. 2016 Oct;102(4):1391-9. doi: 10.1016/j.athoracsur.2016.04.071. Epub 2016 Jun 22.

    PubMed 27344279

Questions about this trial

What is this clinical trial studying?

A study testing Routine thermal management and Target temperature management in people with Cancer Surgery and Intraoperative Hypothermia, run by Peking University First Hospital at 36 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong-Xin Wang, MD, PhD (8610 83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of delirium within 4 days after surgery (time frame: During the first four days after surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06256354, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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