Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery

July 29, 2025 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

4532

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
        • Contact:
          • Sheng Wang
          • Phone Number: +86 19156007726
        • Contact:
      • Hefei, Anhui, China, 065001
        • Recruiting
        • The First Affiliated Hospital of China University of Science and Technology
        • Contact:
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 100040
        • Recruiting
        • Tsinghua University Yuquan Hospital
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 200032
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
        • Contact:
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:
        • Contact:
      • Fuzhou, Fujian, China, 350004
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:
      • Fuzhou, Fujian, China, Fujian
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
        • Contact:
      • Jinjiang, Fujian, China, 362261
        • Recruiting
        • Jinjiang City Hospital (Shanghai Sixth People's Hospital, Fujian Hospital)
        • Contact:
          • Wujiu Le, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong General Hospital
        • Contact:
        • Contact:
      • Shenzhen, Guangdong, China, 518035
      • Shenzhen, Guangdong, China, 518034
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Affiliated Cancer Hospital of Guangxi Medical University
        • Contact:
          • Linghui Pan
          • Phone Number: +86 18077168637
        • Contact:
      • Nanning, Guangxi, China, 530005
        • Recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
        • Contact:
    • Hangzhou
      • Zhejiang, Hangzhou, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
        • Contact:
      • Tangshan, Hebei, China, 063000
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
        • Contact:
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The first affiliated hospital of Zhengzhou university
        • Contact:
        • Contact:
      • Zhengzhou, Henan, China, 463599
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410119
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
        • Contact:
      • Hengyang, Hunan, China, 421005
        • Not yet recruiting
        • The First Affiliated Hospital of University of South China
        • Contact:
        • Contact:
          • Rongjun Wu
          • Phone Number: +86 15074749477
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Affiliated Drum Tower Hospital, Medical School of Nanjing University
        • Contact:
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing General Hospital of Nanjing Military Region
        • Contact:
          • Lidong Zhang, MD
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Suzhou University
        • Contact:
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130031
        • Recruiting
        • Bethune First Hospital Of Jilin University
        • Contact:
        • Contact:
    • Nanjing
      • Nanjing, Nanjing, China, 210002
        • Not yet recruiting
        • General Hospital of Eastern Theater Command
        • Contact:
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750003
        • Not yet recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Xinli Ni
          • Phone Number: +86 13909586966
        • Contact:
      • Yinchuan, Ningxia, China, 750011
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital, Fourth Military Medical University
        • Contact:
        • Contact:
    • Shandong
      • Heze, Shandong, China, 274000
        • Recruiting
        • Shandong Provincial Hospital Heze Hospital
        • Contact:
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Recruiting
        • Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
        • Contact:
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
          • Weiwei Zhang, MD
      • Taiyuan, Shanxi, China, 030032
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
          • Hua Zheng, MD
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Qingong Zhang, MD
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Recruiting
        • First Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Other Names:
  • Dexmedetomidine hydrochloride
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.
Drug: 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 Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival after surgery
Time Frame: 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.
Up to 3 years after surgery of the last enrolled patient.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative delirium.
Time Frame: 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.
During the first 4 postoperative days.
Incidence of cognitive dysfunction at 6 months and 1 year postoperatively.
Time Frame: 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.
At 6 months and 1 year postoperatively.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in hospital after surgery.
Time Frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Up to 30 days after surgery.
Overall survival after surgery
Time Frame: Up to 3 years after surgery of the last enrolled patient.
Time interval from index surgery to all-cause death.
Up to 3 years after surgery of the last enrolled patient.
Event-free survival after surgery
Time Frame: Up to 3 years after surgery of the last enrolled patient.
Time interval from index surgery to cancer recurrence/metastasis/progression, new-onset cancer, new-onset serious illness (requiring hospitalization), or all-cause death, whichever comes first.
Up to 3 years after surgery of the last enrolled patient.
Cancer-specific survival after surgery
Time Frame: Up to 3 years after surgery of the last enrolled patient.
Time interval from index surgery to cancer-specific death, with deaths from other causes being censored at the time of death. Cancer-specific death is defined as death fully attributable to the cancer for which the index surgery is performed and usually involves cancer recurrence/metastasis/progression after exclusion of other causes such as stroke and myocardial infarction.
Up to 3 years after surgery of the last enrolled patient.
Rate of intensive care unit (ICU) admission after surgery.
Time Frame: Up to 30 days after surgery.
Percentage of patients who required ICU admission within 30 days after surgery.
Up to 30 days after surgery.
Incidence of postoperative complications within 30 days.
Time Frame: Up to 30 days after surgery.
Postoperative complications are defined as new-onset medical events other than delirium that are deemed harmful and require therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.
Up to 30 days after surgery.
Subjective sleep quality after surgery.
Time Frame: During the first 4 postoperative days.
Subjective sleep quality will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=the best sleep and 10=the worst sleep) once daily during the first 4 postoperative days.
During the first 4 postoperative days.
Intensity of pain after surgery.
Time Frame: Two hours after surgery and during the first 4 postoperative days.
Intensity of pain will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) twice daily during the first 4 postoperative days.
Two hours after surgery and during the first 4 postoperative days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University

Investigators

  • Principal Investigator: Dong-Xin Wang, MD,PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

September 3, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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