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Spots Global Cancer Trial Database for Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery

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Trial Identification

Brief Title: 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 ID: NCT06030804

Study Description

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

Minimum Age: 60 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Peking University First Hospital, Beijing, Beijing, China, China

Tsinghua University Yuquan Hospital, Beijing, Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China

The First Affiliated Hospital of Army Medical University (Southwest Hospital), Chongqing, Chongqing, 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

Guangdong General Hospital, Guangzhou, Guangdong, China

Peking University Shenzhen Hospital, Shenzhen, Guangdong, China

The First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China

Affiliated Cancer Hospital of Guangxi Medical University, Nanning, Guangxi, China

The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China

Zhejiang Cancer Hospital, Zhejiang, Hangzhou, China

The First Affiliated Hospital of China University of Science and Technology, Hefei, Hebei, China

The First Affiliated Hospital of China University of Science and Technology(Anhui Provincial Hospital), Hefei, Hebei, 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

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, China

First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

Contact Details

Name: Dong-Xin Wang, MD,PhD

Affiliation: Peking University First Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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