Impact of Perioperative Dexmedetomidine on Long-term Survival in Older Patients After Cancer Surgery: a Multicenter Randomized Trial

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Aged 60 years or older.

• Scheduled to undergo radical surgery for cancer under general anesthesia, with an expected surgical duration of 2 hours or longer.

• Required patient-controlled intravenous analgesia after surgery.

Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Tsinghua University Yuquan Hospital
RECRUITING
Beijing
Bethune First Hospital Of Jilin University
RECRUITING
Changchun
Xiangya Hospital Central South university
RECRUITING
Changsha
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
RECRUITING
Chongqing
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Fujian Provincial Hospital
RECRUITING
Fuzhou
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Guangdong General Hospital
RECRUITING
Guangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The First Affiliated Hospital of China University of Science and Technology
RECRUITING
Hefei
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
RECRUITING
Hefei
The First Affiliated Hospital of University of South China
NOT_YET_RECRUITING
Hengyang
Shandong Provincial Hospital Heze Hospital
RECRUITING
Heze
Jinjiang City Hospital (Shanghai Sixth People's Hospital, Fujian Hospital)
RECRUITING
Jinjiang
Affiliated Drum Tower Hospital, Medical School of Nanjing University
RECRUITING
Nanjing
General hospital of eastern theater command
NOT_YET_RECRUITING
Nanjing
Nanjing General Hospital of Nanjing Military Region
RECRUITING
Nanjing
Affiliated Cancer Hospital of Guangxi Medical University
RECRUITING
Nanning
The Second Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
RECRUITING
Shanghai
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
The First Affiliated Hospital of Shenzhen University
RECRUITING
Shenzhen
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Suzhou University
RECRUITING
Suzhou
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Shanxi Provincial People's Hospital
RECRUITING
Taiyuan
Tangshan Workers' Hospital
NOT_YET_RECRUITING
Tangshan
First Affiliated Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Xijing Hospital, Fourth Military Medical University
RECRUITING
Xi'an
General Hospital of Ningxia Medical University
NOT_YET_RECRUITING
Yinchuan
People's Hospital of Ningxia Hui Autonomous Region
RECRUITING
Yinchuan
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Zhejiang
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Dong-Xin Wang, MD,PhD
wangdongxin@hotmail.com
8610 83572784
Backup
Jia-Hui Ma, PhD
mjh@bjmu.edu.cn
8610 83575138
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2028-10
Participants
Target number of participants: 4532
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Peking University First Hospital
Collaborators: Peking University

This content was sourced from clinicaltrials.gov