NCT06030804

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,532

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

39 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Sep 2023Oct 2028

First Submitted

Initial submission to the registry

September 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Expected
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

September 3, 2023

Last Update Submit

July 29, 2025

Conditions

ElderlyCancer SurgeryDexmedetomidineLong-Term Survivors

Keywords

Older patientsCancer surgeryDexmedetomidineLong-term survival

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival after surgery

    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 Outcomes (2)

  • Incidence of postoperative delirium.

    During the first 4 postoperative days.

  • Incidence of cognitive dysfunction at 6 months and 1 year postoperatively.

    At 6 months and 1 year postoperatively.

Other Outcomes (8)

  • Rate of intensive care unit (ICU) admission after surgery.

    Up to 30 days after surgery.

  • Intensity of pain after surgery.

    Two hours after surgery and during the first 4 postoperative days.

  • Subjective sleep quality after surgery.

    During the first 4 postoperative days.

  • +5 more other outcomes

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

DexmedetomidineDRUG

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.

Also known as: Dexmedetomidine hydrochloride
Dexmedetomidine group
PlaceboDRUG

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.

Also known as: Normal saline
Control group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to communicate preoperatively due to visual, auditory, verbal. or other reasons.
  • Surgery for breast cancer or intracranial tumor.
  • Preoperative severe sinus bradycardia (\<50 beats per minute), sick sinus syndrome，or second-degree or above atrioventricular block without pacemaker.
  • Severe hepatic dysfunction (Child-Pugh class C).
  • Severe renal dysfunction (requirement of renal replacement therapy before surgery).
  • Enrolled in other clinical studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

The First Affiliated Hospital of China University of Science and Technology

Hefei, Anhui, 065001, China

RECRUITING

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

Hefei, Anhui, 230001, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Tsinghua University Yuquan Hospital

Beijing, Beijing Municipality, 100040, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 200032, China

RECRUITING

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

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, Fujian, China

NOT YET RECRUITING

Jinjiang City Hospital (Shanghai Sixth People's Hospital, Fujian Hospital)

Jinjiang, Fujian, 362261, China

RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518034, China

RECRUITING

The First Affiliated Hospital of Shenzhen University

Shenzhen, Guangdong, 518035, China

RECRUITING

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530005, China

RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, 310022, China

NOT YET RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Tangshan Workers' Hospital

Tangshan, Hebei, 063000, China

NOT YET RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 463599, China

RECRUITING

Xiangya Hospital Central South university

Changsha, Hunan, 410119, China

RECRUITING

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421005, China

NOT YET RECRUITING

Nanjing General Hospital of Nanjing Military Region

Nanjing, Jiangsu, 210000, China

RECRUITING

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

The Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215004, China

RECRUITING

Bethune First Hospital Of Jilin University

Changchun, Jilin, 130031, China

RECRUITING

General hospital of eastern theater command

Nanjing, Nanjing, 210002, China

NOT YET RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750003, China

NOT YET RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750011, China

RECRUITING

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Shandong Provincial Hospital Heze Hospital

Heze, Shandong, 274000, China

RECRUITING

Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

RECRUITING

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (30)

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    PMID: 27275778BACKGROUND

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  • Shakhar G, Ben-Eliyahu S. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol. 2003 Oct;10(8):972-92. doi: 10.1245/aso.2003.02.007.

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  • Xing MW, Li CJ, Guo C, Wang BJ, Mu DL, Wang DX. Effect of intraoperative dexmedetomidine on long-term survival in older patients after major noncardiac surgery: 3-year follow-up of a randomized trial. J Clin Anesth. 2023 Jun;86:111068. doi: 10.1016/j.jclinane.2023.111068. Epub 2023 Feb 1.

    PMID: 36736209BACKGROUND

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MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dong-Xin Wang, MD,PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD,PhD

CONTACT

8610 83572784wangdongxin@hotmail.com

Jia-Hui Ma, PhD

CONTACT

8610 83575138mjh@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Department of Anesthesiology

Study Record Dates

First Submitted

September 3, 2023

First Posted

September 11, 2023

Study Start

September 12, 2023

Primary Completion

September 1, 2025

Study Completion (Estimated)

October 1, 2028

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(39)