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

NCT07655687 | Not Yet Recruiting DMC

• 1 other identifier: 2026R0324
• Study Type: interventional
• Target: 1,512
• Locations: 1 country
• Sites: 2

Brief 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. 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

Elderly Patients; Cancer Surgery; Hypothermia, Accidental; Targeted Temperature Management; Delayed Neurocognitive Recovery

Keywords

elderly patient; major cancer surgery; intraoperativ hypothermia; targeted temperature management; delayed neurocognitive recovery

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (2)

• Incidence of postoperative delirium

  Up to 4 days after surgery

• Incidence of postoperative neurocognitive disorder

  At 30 days after surgery

Other Outcomes (9)

• Postoperative thermal discomfort

  Up to 30 minutes after arriving PACU/ICU or after extubation

• Postoperative shivering intensity

  Up to 30 minutes after arriving PACU/ICU or after extubation

• Quality of recovery on postoperative day 1

  At 24 hours after surgery

Study Arms (2)

Target temperature management

EXPERIMENTAL

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.

Other: Target temperature management

Routine thermal management

OTHER

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.

Other: Routine thermal management

Interventions

Target temperature management OTHER

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.

Target temperature management

Routine thermal management OTHER

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.

Routine thermal management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Shenzhen Hospital: collaborator

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

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MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong-Xin U Wang

  Dong-Xin Wang, MD, PhD, Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

010-83572784; wangdongxin@hotmail.com

Qian Dong, MD

CONTACT

dongqian25@stu.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician, Department of Anesthesiology, Peking University First Hospital

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)