Clinical trial NCT06030804: Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
Official title: Impact of Perioperative Dexmedetomidine on Long-term Survival in Older Patients After Cancer Surgery: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elderly
Cancer Surgery
Dexmedetomidine
Long-Term Survivors
Keywords: Older patients
Cancer surgery
Dexmedetomidine
Long-term survival
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2023-09-11
Enrollment: 4532
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion criteria:

1. Aged 60 years or older.
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:

1. Inability to communicate preoperatively due to visual, auditory, verbal. or other reasons.
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.

Primary outcomes:
measure: Progression-free survival after surgery
timeFrame: Up to 3 years after surgery of the last enrolled patient.
Secondary outcomes:
measure: Incidence of postoperative delirium.
timeFrame: During the first 4 postoperative days.
measure: Incidence of cognitive dysfunction at 6 months and 1 year postoperatively.
timeFrame: At 6 months and 1 year postoperatively.
Other outcomes:
measure: Rate of intensive care unit (ICU) admission after surgery.
timeFrame: Up to 30 days after surgery.
measure: Intensity of pain after surgery.
timeFrame: Two hours after surgery and during the first 4 postoperative days.
measure: Subjective sleep quality after surgery.
timeFrame: During the first 4 postoperative days.
measure: Length of stay in hospital after surgery.
timeFrame: Up to 30 days after surgery.
measure: Incidence of postoperative complications within 30 days.
timeFrame: Up to 30 days after surgery.
measure: Overall survival after surgery
timeFrame: Up to 3 years after surgery of the last enrolled patient.
measure: Cancer-specific survival after surgery
timeFrame: Up to 3 years after surgery of the last enrolled patient.
measure: Event-free survival after surgery
timeFrame: Up to 3 years after surgery of the last enrolled patient.
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing, China
city: Beijing
country: China
facility: Tsinghua University Yuquan Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Army Medical University (Southwest Hospital)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The First Affiliated Hospital of Shenzhen University
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: The Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
state: Hangzhou
city: Hefei
country: China
facility: The First Affiliated Hospital of China University of Science and Technology
state: Hebei
city: Hefei
country: China
facility: The First Affiliated Hospital of China University of Science and Technology(Anhui Provincial Hospital)
state: Hebei
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Tangshan
country: China
facility: Tangshan Workers' Hospital
state: Hebei
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital Central south university
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Suzhou University
state: Jiangsu
city: Changchun
country: China
facility: Bethune First Hospital Of Jilin University
state: Jilin
city: Nanjing
country: China
facility: General hospital of eastern theater command
state: Nanjing
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
city: Heze
country: China
facility: Shandong Provincial Hospital Heze Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
state: Shanghai
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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