Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
- Conditions
- ElderlyCancer SurgeryDexmedetomidineLong-Term Survivors
- Interventions
- Drug: Placebo
- Registration Number
- NCT06030804
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
Along with aging population, cancer incidence and mortality are increasing. However, despite advances in oncology and surgery, long-term survival of cancer patients is far from optimal. Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist with sedative, analgesic, and anxiolytic effects. Studies showed that perioperative use of dexmedetomidine reduces delirium and some non-delirium complications after surgery. In long-term follow-up studies of older patients who, for other reasons, were randomized to receive either dexmedetomidine or placebo during intra- or postoperative period, dexmedetomidine use was associated with improved long-term survival. This multicenter randomized trial aims to investigate the effect of perioperative dexmedetomidine on long-term outcomes in older patients undergoing cancer surgery.
- Detailed Description
Along with aging population, cancer incidence and mortality are increasing. Surgical resection remains the mainstay treatment for solid organ cancer. However, despite advances in oncology and surgery, long-term survival of cancer patients is far from optimal. For example, the 5-year survival rate of cancer patients is about 36.9% in China, and the survival rate decreases for about 10% each year in older patients after cancer surgery. How to improve long-term survival after cancer surgery remains an urgent problem to be solved.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4532
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group 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. Dexmedetomidine group 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/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.
- Primary Outcome Measures
Name Time Method Progression-free survival after surgery Up to 3 years after surgery of the last enrolled patient. Time interval from index surgery to cancer recurrence/metastasis/progression or all-cause death, whichever comes first.
- Secondary Outcome Measures
Name Time Method Incidence of postoperative delirium. During the first 4 postoperative days. Delirium will be assessed with the 3D-Confusion Assessment Method (3D-CAM) or CAM for the Intensive Care Unit (CAM-ICU) twice daily during the first 4 postoperative days.
Incidence of cognitive dysfunction at 6 months and 1 year postoperatively. At 6 months and 1 year postoperatively. Cognitive function will be assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) before surgery and at 6 months and 12 months after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline will be considered occurrence of cognitive dysfunction.
Trial Locations
- Locations (34)
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
The First Affiliated Hospital of Shenzhen University
🇨🇳Shenzhen, Guangdong, China
The First Affiliated Hospital of China University of Science and Technology(Anhui Provincial Hospital)
🇨🇳Hefei, Hebei, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Bethune First Hospital Of Jilin University
🇨🇳Changchun, Jilin, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Affiliated Cancer Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The Second Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of China University of Science and Technology
🇨🇳Hefei, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, 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
General hospital of eastern theater command
🇨🇳Nanjing, Nanjing, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
🇨🇳Nanjing, Jiangsu, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
People's Hospital of Ningxia Hui Autonomous Region
🇨🇳Yinchuan, Ningxia, China
Shandong Provincial Hospital Heze Hospital
🇨🇳Heze, Shandong, China
Xijing Hospital, Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Tsinghua University Yuquan Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
🇨🇳Chongqing, Chongqing, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Tangshan Workers' Hospital
🇨🇳Tangshan, Hebei, China
Zhejiang Cancer Hospital
🇨🇳Zhejiang, Hangzhou, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China, China