Clinical trial · Interventional
Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery
Intraoperative Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery: a Multicenter Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Surgery | — | UNRESOLVED | — |
| Delayed Neurocognitive Recovery | — | UNRESOLVED | — |
| Elderly Patients | — | UNRESOLVED | — |
| Hypothermia, Accidental | — | UNRESOLVED | — |
| Targeted Temperature Management | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine thermal management | Other | — | UNRESOLVED |
| Target temperature management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Target temperature management
- description
- 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 to maintain core temperature. The goal is to maintain core temperature at 36.8°C.
- interventionNames
- Other: Target temperature management
- type
- OTHER
- label
- Routine thermal management
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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 schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or preexisting delirium. 4. Inability to communicate due to coma, severe dementia, or hearing or speech impairment. 5. 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. 6. Surgery for breast cancer, intracranial tumors, or rare cancers. 7. Planned to undergo therapeutic hypothermia. 8. Body mass index \> 30 kg/m² (to facilitate temperature management). 9. Previous enrollment in this study. 10. Other conditions deemed unsuitable for study participation.
References
Publications (45)
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- BACKGROUNDKatayama 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. PMID 26289837
- BACKGROUNDHorn 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. PMID 9778005
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- BACKGROUNDShinall 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.