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Elderly PatientsNCT07655687

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

A study testing Target temperature management and Routine thermal management in people with Elderly Patients and Cancer Surgery, run by Peking University First Hospital at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Target temperature management and Routine thermal management
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,512 participants
Where
2 sitesChina
Study dates
Jun 2026to Nov 2028
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
  • Healthy volunteers accepted
  • 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 schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or preexisting delirium.
  • Inability to communicate due to coma, severe dementia, or hearing or speech impairment.
  • Critically ill patients, defined as NYHA functional class > III or LVEF < 30%, Child-Pugh class C, preoperative dialysis dependence, ASA physical status > IV, or expected survival < 24 hours.
  • 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 temperature management).
  • Previous enrollment in this study.
  • Other conditions deemed unsuitable for study participation.

Trial locations and contacts

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

Dong-Xin Wang, MD, PhD contact

010-83572784

wangdongxin@hotmail.com

Qian Dong, MD contact

dongqian25@stu.pku.edu.cn

China2 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Dong-Xin Wang, MD, PhD, 010-83572784, wangdongxin@hotmail.com

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

    Tao Luo, MD, 496855048@qq.com

Other trials in China

About this study

Official title: Intraoperative Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery: a Multicenter Randomized Trial

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.

Read the detailed description

With aging population, more older patients will undergo major surgery for cancer. Due to age-related cognitive decline, cancer-related frailty, as well as impacts from surgical trauma and anesthesia, older patients are at increased risk of postoperative neurocognitive complications including delayed neurocognitive recovery (dNCR), which refers to new-onset cognitive decline within 30 days after surgery. Studies reported that the incidence of dNCR within 7 days ranges from 23.2% to 41.4% in older patients after non-cardiac surgery. Patients with dNCR tend to have prolonged hospital stay, impaired quality of life, and even increased long-term cognitive disorders, and thus imposing a heavy burden on patients, their families, and the healthcare system.

The occurrence of dNCR after surgery results from the combined effects of predisposing factors (e.g., advanced age, preoperative cognitive impairment, comorbidities, malnutrition) and precipitating factors (e.g., anesthetic management, surgical stress, residual drug effects, postoperative complications). Among modifiable precipitating factors, unintended intraoperative hypothermia (core temperature <36 °C) is a common yet long underappreciated clinical issue. Due to prolonged operative duration, extensive body cavity exposure, and massive intraoperative fluid and blood transfusion, patients undergoing major cancer surgery have an incidence of intraoperative hypothermia between 57.1% and 78.6%.

Previous studies demonstrated that a core temperature below 35.5 °C is associated with multiple adverse events, including higher risks of intraoperative bleeding and blood transfusion and postoperative surgical site infections. The international multicenter randomized controlled PROTECT trial enrolled 5,056 patients over 45 years undergoing major non-cardiac surgery but found no significant differences in postoperative myocardial injury, surgical site infection, and blood loss between the routine management group (core temperature 35.5 °C) and the active warming group (core temperature 37 °C); these indicated that maintaining core temperature at 35.5 °C is safe with regard to these complications. However, neurocognitive function was not assessed in the PROTECT trial. Whether an intraoperative temperature of 35.5 °C is safe for the neurocognitive outcomes requires further investigation.

The pathogenesis of neurocognitive complications is complex, involving multiple pathological processes such as neuroinflammation, blood-brain barrier disruption, oxidative stress, and hippocampal neuronal injury. Perioperative hypothermia may trigger similar pathophysiological changes. Studies showed that hypothermia suppresses the immune function and promotes the release of peripheral pro-inflammatory cytokines including IL-6 and IL-1β, and thereby exacerbating central neuroinflammation, which is one of the core mechanisms underlying dNCR. Animal experiments demonstrated that hypothermia-induced cognitive dysfunction is associated with damage to hippocampal neurons and reduced expression of proteins related to synaptic plasticity. Furthermore, hypothermia impairs the metabolism of anesthetics and prolongs emergence time, which may contribute to the early manifestations of postoperative cognitive dysfunction.

There is still a lack of definitive evidence regarding whether intraoperative targeted temperature management can reduce dNCR in older patients undergoing major cancer surgery. Meanwhile, there remains debate over the hypothermia threshold and optimal target temperature range. We are currently conducting a multicenter randomized trial to verify whether intraoperative targeted temperature management (36.8 °C) reduces the incidence of delirium within 4 days in older patients after major cancer surgery. Based on patients enrolled at our institution, 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 delayed neurocognitive recovery in older patients undergoing major cancer surgery.

Being tested
Target temperature management, Routine thermal management
Keywords
elderly patient, major cancer surgery, intraoperativ hypothermia, targeted temperature management, delayed neurocognitive recovery
Medical subject headings
Hypothermia

What participants receive

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

  • Target temperature managementOther

    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 managementOther

    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 groups in NCT07655687
Study groupRoleWhat they receive
Target temperature managementExperimentalPre-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 to maintain core temperature. The goal is to maintain core temperature at 36.8°C.
Receives: Other: Target temperature management
Routine thermal managementOtherPre-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.
Receives: Other: Routine thermal management

What is being measured

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

  1. Incidence of delayed neurocognitive recovery (dNCR)

    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).

    Measured: At 5 days after surgery or before hospital discharge, whichever came first

Secondary outcomes (2)

  1. Incidence of postoperative delirium

    Delirium will be assessed twice daily (8-10 am and 6-8 pm) using the 3-Dimensional Confusion Assessment Method (3D-CAM) for patients without intubation or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for patients with intubation.

    Measured: Up to 4 days after surgery

  2. Incidence of postoperative neurocognitive disorder

    Cognitive function will be assessed at baseline using MoCA (MoCA-22; scores range from 0 to 22, with higher scores indicating better cognitive function) and at 30 days after surgery using MoCA via telephone (T-MoCA; scores range from 0 to 22, with higher scores indicating better cognitive function).

    Postoperative neurocognitive disorder (pNCD) 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 nonsurgical group)] / (standard deviation of change from baseline in MoCA score in the non-surgical group).

    Measured: At 30 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 posted18 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionNov 2028 (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
1,512 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07655687
Sponsor's protocol ID
2026R0324
Status last verified
Jun 2026
First submitted
13 Jun 2026
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

  • Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.

    PubMed 21818162

  • Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.

    PubMed 26775126

  • Sessler DI. Perianesthetic thermoregulation and heat balance in humans. FASEB J. 1993 May;7(8):638-44. doi: 10.1096/fasebj.7.8.8500688.

    PubMed 8500688

  • Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today. 2016 Jun;46(6):668-85. doi: 10.1007/s00595-015-1236-x. Epub 2015 Aug 20.

    PubMed 26289837

  • Horn EP, Sessler DI, Standl T, Schroeder F, Bartz HJ, Beyer JC, Schulte am Esch J. Non-thermoregulatory shivering in patients recovering from isoflurane or desflurane anesthesia. Anesthesiology. 1998 Oct;89(4):878-86. doi: 10.1097/00000542-199810000-00012.

    PubMed 9778005

  • Kurz A, Sessler DI, Narzt E, Bekar A, Lenhardt R, Huemer G, Lackner F. Postoperative hemodynamic and thermoregulatory consequences of intraoperative core hypothermia. J Clin Anesth. 1995 Aug;7(5):359-66. doi: 10.1016/0952-8180(95)00028-g.

    PubMed 7576669

  • Shinall MC Jr, Arya S, Youk A, Varley P, Shah R, Massarweh NN, Shireman PK, Johanning JM, Brown AJ, Christie NA, Crist L, Curtin CM, Drolet BC, Dhupar R, Griffin J, Ibinson JW, Johnson JT, Kinney S, LaGrange C, Langerman A, Loyd GE, Mady LJ, Mott MP, Patri M, Siebler JC, Stimson CJ, Thorell WE, Vincent SA, Hall DE. Association of Preoperative Patient Frailty and Operative Stress With Postoperative Mortality. JAMA Surg. 2020 Jan 1;155(1):e194620. doi: 10.1001/jamasurg.2019.4620. Epub 2020 Jan 15.

    PubMed 31721994

  • Rajek A, Greif R, Sessler DI, Baumgardner J, Laciny S, Bastanmehr H. Core cooling by central venous infusion of ice-cold (4 degrees C and 20 degrees C) fluid: isolation of core and peripheral thermal compartments. Anesthesiology. 2000 Sep;93(3):629-37. doi: 10.1097/00000542-200009000-00010.

    PubMed 10969294

  • Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.

    PubMed 7879936

  • Bock M, Muller J, Bach A, Bohrer H, Martin E, Motsch J. Effects of preinduction and intraoperative warming during major laparotomy. Br J Anaesth. 1998 Feb;80(2):159-63. doi: 10.1093/bja/80.2.159.

    PubMed 9602578

  • Camus Y, Delva E, Sessler DI, Lienhart A. Pre-induction skin-surface warming minimizes intraoperative core hypothermia. J Clin Anesth. 1995 Aug;7(5):384-8. doi: 10.1016/0952-8180(95)00051-i.

    PubMed 7576673

  • Just B, Trevien V, Delva E, Lienhart A. Prevention of intraoperative hypothermia by preoperative skin-surface warming. Anesthesiology. 1993 Aug;79(2):214-8. doi: 10.1097/00000542-199308000-00004.

    PubMed 8251019

  • Vanni SM, Braz JR, Modolo NS, Amorim RB, Rodrigues GR Jr. Preoperative combined with intraoperative skin-surface warming avoids hypothermia caused by general anesthesia and surgery. J Clin Anesth. 2003 Mar;15(2):119-25. doi: 10.1016/s0952-8180(02)00512-3.

    PubMed 12719051

  • Wong PF, Kumar S, Bohra A, Whetter D, Leaper DJ. Randomized clinical trial of perioperative systemic warming in major elective abdominal surgery. Br J Surg. 2007 Apr;94(4):421-6. doi: 10.1002/bjs.5631.

    PubMed 17380549

  • Matsukawa T, Sessler DI, Christensen R, Ozaki M, Schroeder M. Heat flow and distribution during epidural anesthesia. Anesthesiology. 1995 Nov;83(5):961-7. doi: 10.1097/00000542-199511000-00008.

    PubMed 7486181

Questions about this trial

What is this clinical trial studying?

A study testing Target temperature management and Routine thermal management in people with Elderly Patients and Cancer Surgery, run by Peking University First Hospital at 2 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: opening soon, 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 2 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. 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 (010-83572784, 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 delayed neurocognitive recovery (dNCR) (time frame: At 5 days after surgery or before hospital discharge, whichever came first). 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 NCT07655687, which also lists 45 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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