ElderlyNCT06030804
Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
A study testing Dexmedetomidine in people with Elderly and Cancer Surgery, run by Peking University First Hospital at 40 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly, Cancer Surgery, Dexmedetomidine
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,532 participants
- Where
- 40 sitesChina
- Study dates
- 12 Sep 2023to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
China40 sites, 40 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dong-Xin Wang, MD, PhD, 8610 83572784, wangdongxin@hotmail.com
Jia-Hui Ma, PhD, 8610 83575138, mjh@bjmu.edu.cn
- Recruiting
Tsinghua University Yuquan Hospital
Beijing, Beijing Municipality, 100040
Ting Fan, +86 13681100715, 1368110715@163.com
Yao Chen, +86 13681100715, 15210079723@163.com
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 200032
Hui Zheng, +86 13811516861, 1060204797@qq.com
Chaoqun Liu, +86 13722148630, 1060204797@qq.com
- Recruiting
Bethune First Hospital Of Jilin University
Changchun, Jilin, 130031
Xuefeng Song, MD, +86 15804300395, songxs@jlu.edu.cn
Lin Hou, +86 15243110723, houlinjdyy@jlu.edu.cn
- Recruiting
Xiangya Hospital Central South university
Changsha, Hunan, 410119
E Wang, MD, +86 18874889950, ewang324@csu.edu.cn
Ning Luo, +86 13548681993, hnrollin@163.com
- Recruiting
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Chongqing, Chongqing Municipality, 400038
Jianteng Gu, +86 13983716009, gjt1976@163.com
Jianbo Ma, +86 18375722461, smmu2001@126.com
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Xiaochun Zheng, +86 13705058351, zhengxc2@163.com
Zhibin Huang, +86 13265068315, huangzhibin1122@sina.com
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Xianzhong Lin, +86 13509350812, lxzyjs@fjmu.edu.cn
Jinghao Huang, +86 13405987180, 250832306@qq.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, Fujian
Liangcheng Zhang, +86 13365910567, zhanglc6@163.com
Danfeng Zhang, +86 18150027862, mazui1234@163.com
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Haihua Shu, +86 13427536899, shuhaihua@hotmail.com
Qimin Ouyang, +86 15088092989, 506590580@qq.com
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Bing Zhang, +86 13796620602, zhang_bing08@162.com
Wang Yang, +86 15804616875, yangwang1105@163.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Fei Han, +86 18686857197, fh.feih@yahoo.com
Zhaodi Zhang, +86 13936550681, jody1982@163.com
- Recruiting
The First Affiliated Hospital of China University of Science and Technology
Hefei, Anhui, 065001
Juan Li, +86 13956005465, huamuzi1999@126.com
Mingming Han, +86 15856972325, hanmingming@ustc.edu.cn
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230001
Sheng Wang, +86 19156007726
Keqiang He, +86 13965008903, doctorhector@ustc.edu.cn
- Not yet recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421005
Chao Li, +86 13575158507, 8993328@qq.com
Rongjun Wu, +86 15074749477
- Recruiting
Shandong Provincial Hospital Heze Hospital
Heze, Shandong, 274000
Haifeng Wang, +86 18753008388, whf2566@163.com
Changwei Qu, qchw1988@163.com
- Recruiting
Jinjiang City Hospital (Shanghai Sixth People's Hospital, Fujian Hospital)
Jinjiang, Fujian, 362261
Wujiu Le, MD
- Recruiting
Nanjing General Hospital of Nanjing Military Region
Nanjing, Jiangsu, 210000
Lidong Zhang, MD
- Recruiting
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
Xiaoping Gu, +86 13813996903, xiaopinggu@nju.edu.cn
Liangyu Peng, +86 18073401576, peng-liangyu@smail.nju.edu.cn
- Not yet recruiting
General hospital of eastern theater command
Nanjing, Nanjing, 210002
Lidong Zhang, +86 13813830135, ldzhang1968@163.com
Hao Cheng, +86 18252056281, chenghao927@126.com
- Recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530005
Xueke Du, +86 13707888675, 46699644@qq.com
Yi Wei, +86 13481052580, 271998683@qq.com
- Recruiting
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Linghui Pan, +86 18077168637
Liang Guo, +86 13707711621, 1159398818@qq.com
- Recruiting
Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200123
Lize Xiong, MD, +86 13609283068, mzkxlz@126.com
Xiya Yu, MD, +86 13764210333, yuxiyash@163.com
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518034
Tao Luo, +86 13510820779, 496855048@qq.com
Dongling Chen, +86 15919852236, 524057961@qq.com
- Recruiting
The First Affiliated Hospital of Shenzhen University
Shenzhen, Guangdong, 518035
Zhiheng Liu, 15818585570@163.com
Nanbo Liu, 316916645@qq.com
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Chao Li, +86 13831110738, jysylichao@163.com
Fangfang Yong, +86 18531116653, 806442593@qq.com
- Recruiting
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215004
Jiang Zhu, +86 13962153438, zhujiangsz@126.com
Hairui Liu, +86 13584820940, hrhr218@163.com
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Qingong Zhang, MD
- Recruiting
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012
Weiwei Zhang, MD
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Hua Zheng, MD
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
XiaoPeng Wang, M.D., +86 13753133192, 13753133192@163.com
- Not yet recruiting
Tangshan Workers' Hospital
Tangshan, Hebei, 063000
Xiuhua Li, +86 13703250366, 13703250366@163.com
Caijuan Zhang, +86 17713147163, zhangcaijuan006@163.com
- Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Jianrong Ye, +86 18999938777, 616227972@qq.com
Jialing Wang, +86 13319918443, 931701280@qq.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Junlu Wang, +86 13806689854, wangjunlu973@163.com
Yuanyuan Pan, +86 13567780966, panyuanyuan0102@163.com
- Recruiting
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Hai-Long Dong, MD, +86 13669226699, hldong6@hotmail.com
Zhi-Hong Lu, +86 13891975018, deerlu23@163.com
- Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750003
Xinli Ni, +86 13909586966
Lingzi Yin, +86 13014260603, eleven87670@163.com
- Recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750011
Qingshan Ye, yeqingshan@hotmail.com
Xiaohong Zhou, 1123820991@qq.com
- Not yet recruiting
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, 310022
Yuyizi Xie, +86 18857118549, xieyuyizi1984@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Jianjun Yang, MD, +86 13783537619, jianjunyang1971@163.com
Yuzhong Xia, +86 13703923028, yuzhong508@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 463599
Jiaqiang Zhang, +86 13937121360, hnmzxh@163.com
Chunyan Zhang, +86 18539973129, zmsyzcy@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Elderly, Cancer Surgery, Dexmedetomidine, Long-Term Survivors
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Older patients, Cancer surgery, Dexmedetomidine, Long-term survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine hydrochloride
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.
PlaceboDrug
Also called Normal saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival after surgery
Time interval from index surgery to cancer recurrence/metastasis/progression or all-cause death, whichever comes first.
Measured: Up to 3 years after surgery of the last enrolled patient.
Secondary outcomes (2)
Incidence of postoperative delirium.
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.
Measured: During the first 4 postoperative days.
Incidence of cognitive dysfunction 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.
Measured: At 6 months and 1 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start12 Sep 2023
- Primary completionSep 2027 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD,PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030804
- Sponsor's protocol ID
- 2023-227
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
PubMed 29742525Du YT, Li YW, Zhao BJ, Guo XY, Feng Y, Zuo MZ, Fu C, Zhou WJ, Li HJ, Liu YF, Cheng T, Mu DL, Zeng Y, Liu PF, Li Y, An HY, Zhu SN, Li XY, Li HJ, Wu YF, Wang DX, Sessler DI; Peking University Clinical Research Program Study Group. Long-term Survival after Combined Epidural-General Anesthesia or General Anesthesia Alone: Follow-up of a Randomized Trial. Anesthesiology. 2021 Aug 1;135(2):233-245. doi: 10.1097/ALN.0000000000003835.
PubMed 34195784Fokas E, Engenhart-Cabillic R, Daniilidis K, Rose F, An HX. Metastasis: the seed and soil theory gains identity. Cancer Metastasis Rev. 2007 Dec;26(3-4):705-15. doi: 10.1007/s10555-007-9088-5.
PubMed 17786535Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ; Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005 Sep;242(3):326-41; discussion 341-3. doi: 10.1097/01.sla.0000179621.33268.83.
PubMed 16135919Sessler DI. Long-term consequences of anesthetic management. Anesthesiology. 2009 Jul;111(1):1-4. doi: 10.1097/ALN.0b013e3181a913e1. No abstract available.
PubMed 19512884Yamaguchi K, Takagi Y, Aoki S, Futamura M, Saji S. Significant detection of circulating cancer cells in the blood by reverse transcriptase-polymerase chain reaction during colorectal cancer resection. Ann Surg. 2000 Jul;232(1):58-65. doi: 10.1097/00000658-200007000-00009.
PubMed 10862196Page GG, Blakely WP, Ben-Eliyahu S. Evidence that postoperative pain is a mediator of the tumor-promoting effects of surgery in rats. Pain. 2001 Feb 1;90(1-2):191-9. doi: 10.1016/s0304-3959(00)00403-6.
PubMed 11166986Heaney A, Buggy DJ. Can anaesthetic and analgesic techniques affect cancer recurrence or metastasis? Br J Anaesth. 2012 Dec;109 Suppl 1:i17-i28. doi: 10.1093/bja/aes421.
PubMed 23242747Melamed R, Rosenne E, Shakhar K, Schwartz Y, Abudarham N, Ben-Eliyahu S. Marginating pulmonary-NK activity and resistance to experimental tumor metastasis: suppression by surgery and the prophylactic use of a beta-adrenergic antagonist and a prostaglandin synthesis inhibitor. Brain Behav Immun. 2005 Mar;19(2):114-26. doi: 10.1016/j.bbi.2004.07.004.
PubMed 15664784Alazawi W, Pirmadjid N, Lahiri R, Bhattacharya S. Inflammatory and Immune Responses to Surgery and Their Clinical Impact. Ann Surg. 2016 Jul;264(1):73-80. doi: 10.1097/SLA.0000000000001691.
PubMed 27275778Liu S, Yu X, Ye F, Jiang L. Can the systemic inflammation score be used to predict prognosis in gastric cancer patients undergoing surgery? A systematic review and meta-analysis. Front Surg. 2022 Sep 19;9:971326. doi: 10.3389/fsurg.2022.971326. eCollection 2022.
PubMed 36338660Shakhar 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.
PubMed 14527919Payne CJ, Gibson SC, Bryce G, Jardine AG, Berry C, Kingsmore DB. B-type natriuretic peptide predicts long-term survival after major non-cardiac surgery. Br J Anaesth. 2011 Aug;107(2):144-9. doi: 10.1093/bja/aer119. Epub 2011 May 24.
PubMed 21610013
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Dexmedetomidine on Long-term Survival in Older Patients After Cancer Surgery: a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT06030804
- Acronym / sponsor ID
- 2023-227
- Conditions
- Elderly, Cancer Surgery, Dexmedetomidine, Long-Term Survivors
- Keywords
- Older patients, Cancer surgery, Dexmedetomidine, Long-term survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,532 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidineA 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. |
| Control group | Placebo comparator | Drug: PlaceboVolume-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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine hydrochlorideA 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. | Drug | Dexmedetomidine group |
| PlaceboAlso: Normal salineVolume-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 | Control group |
Primary outcome
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.
2 secondary outcomes
Incidence of postoperative delirium.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Background: PubMed 29742525Zhang DF, Su X, Meng ZT, Li HL, Wang DX, Xue-Ying Li, Maze M, Ma D. Impact of Dexmedetomidine on Long-term Outcomes After Noncardiac Surgery in Elderly: 3-Year Follow-up of a Randomized Controlled Trial. Ann Surg. 2019 Aug;270(2):356-363. doi: 10.1097/SLA.0000000000002801.
- Background: PubMed 34195784Du YT, Li YW, Zhao BJ, Guo XY, Feng Y, Zuo MZ, Fu C, Zhou WJ, Li HJ, Liu YF, Cheng T, Mu DL, Zeng Y, Liu PF, Li Y, An HY, Zhu SN, Li XY, Li HJ, Wu YF, Wang DX, Sessler DI; Peking University Clinical Research Program Study Group. Long-term Survival after Combined Epidural-General Anesthesia or General Anesthesia Alone: Follow-up of a Randomized Trial. Anesthesiology. 2021 Aug 1;135(2):233-245. doi: 10.1097/ALN.0000000000003835.
- Background: PubMed 17786535Fokas E, Engenhart-Cabillic R, Daniilidis K, Rose F, An HX. Metastasis: the seed and soil theory gains identity. Cancer Metastasis Rev. 2007 Dec;26(3-4):705-15. doi: 10.1007/s10555-007-9088-5.
- Background: PubMed 16135919Khuri SF, Henderson WG, DePalma RG, Mosca C, Healey NA, Kumbhani DJ; Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005 Sep;242(3):326-41; discussion 341-3. doi: 10.1097/01.sla.0000179621.33268.83.
- Background: PubMed 19512884Sessler DI. Long-term consequences of anesthetic management. Anesthesiology. 2009 Jul;111(1):1-4. doi: 10.1097/ALN.0b013e3181a913e1. No abstract available.
- Background: PubMed 10862196Yamaguchi K, Takagi Y, Aoki S, Futamura M, Saji S. Significant detection of circulating cancer cells in the blood by reverse transcriptase-polymerase chain reaction during colorectal cancer resection. Ann Surg. 2000 Jul;232(1):58-65. doi: 10.1097/00000658-200007000-00009.
- Background: PubMed 11166986Page GG, Blakely WP, Ben-Eliyahu S. Evidence that postoperative pain is a mediator of the tumor-promoting effects of surgery in rats. Pain. 2001 Feb 1;90(1-2):191-9. doi: 10.1016/s0304-3959(00)00403-6.
- Background: PubMed 23242747Heaney A, Buggy DJ. Can anaesthetic and analgesic techniques affect cancer recurrence or metastasis? Br J Anaesth. 2012 Dec;109 Suppl 1:i17-i28. doi: 10.1093/bja/aes421.
- Background: PubMed 15664784Melamed R, Rosenne E, Shakhar K, Schwartz Y, Abudarham N, Ben-Eliyahu S. Marginating pulmonary-NK activity and resistance to experimental tumor metastasis: suppression by surgery and the prophylactic use of a beta-adrenergic antagonist and a prostaglandin synthesis inhibitor. Brain Behav Immun. 2005 Mar;19(2):114-26. doi: 10.1016/j.bbi.2004.07.004.
- Background: PubMed 27275778Alazawi W, Pirmadjid N, Lahiri R, Bhattacharya S. Inflammatory and Immune Responses to Surgery and Their Clinical Impact. Ann Surg. 2016 Jul;264(1):73-80. doi: 10.1097/SLA.0000000000001691.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong-Xin Wang, MD,PhD principal investigator
Peking University First Hospital
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Elderly and Cancer Surgery, run by Peking University First Hospital at 40 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-Xin Wang, MD,PhD (8610 83572784, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival after surgery (time frame: Up to 3 years after surgery of the last enrolled patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06030804, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.