Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
NCT ID: NCT06030804
Last Updated: 2025-07-31
Study Results
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Basic Information
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RECRUITING
NA
4532 participants
INTERVENTIONAL
2023-09-12
2028-10-31
Brief Summary
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Detailed Description
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Cancer death usually occur after cancer recurrence or metastasis. The development of cancer recurrence or metastasise after surgical resection depends on the balance between the anti-cancer defense function of host and the invasiveness of residual cancer cells. Studies showed that surgery, while resecting cancer mass, also releases cancer cells into the circulation. Surgical stress also impairs cell-mediated immunity and promote cancer growth.
Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist with sedative, analgesic, and anxiolytic effects. Studies showed that intraoperative use of dexmedetomidine reduces anesthetic and opioid consumption and relieves surgery-related stress response and inflammation. Studies also showed that perioperative use of dexmedetomidine reduces delirium, a commonly occurred complication in older patients, and some non-delirium complications after surgery.
The effect of perioperative dexmedetomidine on long-term outcomes after cancer surgery remains unclear. In a long-term follow-up of older patients who were randomized to receive either low-dose dexmedetomidine or placebo during intensive care unit stay, dexmedetomidine use was associated with improved survival within 2 years. In a recent long-term follow-up of older patients who were randomized to receive either dexmedetomidine or placebo during surgery, dexmedetomidine use was associated with improved recurrence-free survival.
The investigators hypothesize that perioperative use of dexmedetomidine may improve long-term survival after cancer surgery. This multicenter randomized trial aims to investigate the effect of perioperative dexmedetomidine on long-term outcomes in older patients undergoing cancer surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dexmedetomidine group
A loading dose of dexmedetomidine (0.6 μg/kg) will be administered over 10-15 minutes before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/h till 1 hour before the end of surgery. Patient-controlled dexmedetomidine supplemented sufentanil analgesia will be provided after surgery: the formula contains a mixture of sufentanil (1.25 μg/ml) and dexmedetomidine (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
Dexmedetomidine
A loading dose of dexmedetomidine (0.6 μg/kg) will be administered over 10-15 minutes before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery. Patient-controlled dexmedetomidine supplemented sufentanil analgesia will be provided after surgery: the formula contains a mixture of sufentanil (1.25 μg/ml) and dexmedetomidine (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
Control group
Volume-matched normal saline will be administered in the same rate and volume for the same duration as in the dexmedetomidine group during anesthesia. Patient-controlled sufentanil analgesia will be provided after surgery: the formula contains sufentanil (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
Placebo
Volume-matched normal saline will be administered in the same rate and volume for the same duration as in the dexmedetomidine group during anesthesia. Patient-controlled sufentanil analgesia will be provided after surgery: the formula contains sufentanil (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
Interventions
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Dexmedetomidine
A loading dose of dexmedetomidine (0.6 μg/kg) will be administered over 10-15 minutes before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery. Patient-controlled dexmedetomidine supplemented sufentanil analgesia will be provided after surgery: the formula contains a mixture of sufentanil (1.25 μg/ml) and dexmedetomidine (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
Placebo
Volume-matched normal saline will be administered in the same rate and volume for the same duration as in the dexmedetomidine group during anesthesia. Patient-controlled sufentanil analgesia will be provided after surgery: the formula contains sufentanil (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Scheduled to undergo radical surgery for cancer under general anesthesia, with an expected surgical duration of 2 hours or longer.
3. Required patient-controlled intravenous analgesia after surgery.
Exclusion Criteria
2. Surgery for breast cancer or intracranial tumor.
3. Preoperative severe sinus bradycardia (\<50 beats per minute), sick sinus syndrome，or second-degree or above atrioventricular block without pacemaker.
4. Severe hepatic dysfunction (Child-Pugh class C).
5. Severe renal dysfunction (requirement of renal replacement therapy before surgery).
6. Enrolled in other clinical studies.
60 Years
ALL
No
Sponsors
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Peking University
OTHER
Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology
Principal Investigators
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Dong-Xin Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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The First Affiliated Hospital of China University of Science and Technology
Hefei, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Tsinghua University Yuquan Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Chongqing, Chongqing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Jinjiang City Hospital (Shanghai Sixth People's Hospital, Fujian Hospital)
Jinjiang, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Shenzhen University
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tangshan Workers' Hospital
Tangshan, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South university
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Nanjing General Hospital of Nanjing Military Region
Nanjing, Jiangsu, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Bethune First Hospital Of Jilin University
Changchun, Jilin, China
General hospital of eastern theater command
Nanjing, Nanjing, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
Shandong Provincial Hospital Heze Hospital
Heze, Shandong, China
Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Sheng Wang
Role: primary
Wujiu Le, MD
Role: primary
Linghui Pan
Role: primary
Rongjun Wu
Role: backup
Lidong Zhang, MD
Role: primary
Xinli Ni
Role: primary
Qingong Zhang, MD
Role: primary
Weiwei Zhang, MD
Role: primary
Hua Zheng, MD
Role: primary
References
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Other Identifiers
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2023-227
Identifier Type: -
Identifier Source: org_study_id
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