Clinical trial · Interventional
Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival
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
NCT06256354CI-TRIAL-00115612recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
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 | — |
| Intraoperative Hypothermia | — | UNRESOLVED | — |
| Long-term Survivors | — | UNRESOLVED | — |
| Postoperative Delirium | — | 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
- PLACEBO_COMPARATOR
- label
- Routine thermal management
- description
- 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.
- interventionNames
- Other: Routine thermal management
- type
- EXPERIMENTAL
- label
- Target temperature management
- description
- 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.
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 history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium. 4. Unable to communicate due to severe dementia, language barrier, or coma. 5. 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). 6. Scheduled surgery for breast cancer, intracranial tumors, or rare cancers. 7. Planned to undergo therapeutic hypothermia. 8. Body mass index \>30 kg/m2 (to facilitate thermal management). 9. Have participated in this study previously. 10. Any other conditions that are considered unsuitable for study participation.
References
Publications (53)
- BACKGROUNDHorosz 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. PMID 35100795
- BACKGROUNDRajagopalan 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. PMID 18156884
- BACKGROUNDReynolds 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. PMID 19137808
- BACKGROUNDYi 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. PMID 28594825
- BACKGROUNDKoh 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. PMID 34399681
- BACKGROUNDSun 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. PMID 25603202
- BACKGROUNDSessler 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.