Dexmedetomidine Supplemented Analgesia and Long-term Survival After Cancer Surgery

January 6, 2026 updated by: Dong-Xin Wang, Peking University First Hospital

Impact of Dexmedetomidine Supplemented Analgesia on Long-term Survival in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial

A majority of the elderly patients undergo surgery for malignant tumors. For these patients, postoperative tumor recurrence and metastasis are main factors that worsen long-term outcomes. The investigators hypothesize that dexmedetomidine supplemented analgesia in elderly patients after cancer surgery may help to maintain immune function and improve long-term outcomes, possibly by relieving stress and inflammatory response, improving analgesic efficacy and sleep quality, and reducing delirium incidence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A majority of the elderly patients undergo surgery for malignant tumors. For these patients, postoperative tumor recurrence and metastasis are main factors that worsen the quality of life and shorten the duration of survival. Perioperative immune function is a key element that influences postoperative tumor recurrence and metastasis; but it is subject to the impacts of many factors. Studies showed that elevated cortisol level and inflammation provoked by surgical stress result in suppression of immune function, whereas dexmedetomidine alleviates the elevated cortisol level and inhibit excessive inflammation; high-dose opioids inhibit the immune function and increase the invasiveness of tumor cells, whereas dexmedetomidine reduces the consumption of opioids during perioperative period; postoperative sleep disturbances also impair immune function, whereas dexmedetomidine improves sleep quality in patients after surgery; occurrence of postoperative delirium is associated with increased mortality, whereas dexmedetomidine reduces delirium incidence. The investigators hypothesize that dexmedetomidine supplemented analgesia in elderly patients after cancer surgery may improve the long-term outcomes, possibly by relieving stress and inflammatory response, improving analgesic efficacy and sleep quality, and reducing delirium incidence.

Study Type

Interventional

Enrollment (Actual)

1500

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 Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 100091
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
      • Beijing, Beijing Municipality, China, 102206
        • Peking University International Hospital , , China, Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 408099
        • Chongqing University Fuling Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital , China, Contact:
    • Hebei
      • Baoding, Hebei, China, 050031
        • Affiliated Hospital of Hebei University
    • Hunan
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • The Second Affiliated Hospital of Air Force Medical University
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Qingdao Municipal Hospital , , China, Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital , China, Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300100
        • Tianjin Hospital of ITCWM-Nankai Hospital
      • Tianjin, Tianjin Municipality, China, 300170
        • The Third Central Hospital of Tianjin

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

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >= 65 years, < 90 years;
  • Scheduled to undergo curative resection for primary solid organ cancer under general anesthesia, with an expected duration of surgery >=2 hours;
  • Planned to use patient-controlled intravenous analgesia after surgery;
  • Provide written informed consent.

Exclusion Criteria:

  • Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
  • Preoperative radio- or chemotherapy;
  • Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
  • Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea, or a STOP-Bang score >= 3 and serum HCO3- >= 28 mmol/L);
  • Brain trauma or neurosurgery;
  • Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
  • Severe hepatic dysfunction (Child-Pugh class C) or severe renal dysfunction (requirement of renal replacement therapy before surgery);
  • ASA classification >= IV.

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
Dexmedetomidine supplemented morphine analgesia is provided for patients in this group in the form of patient-controlled intravenous analgesia. The formula contains a mixture of morphine (0.5 mg/ml) and dexmedetomidine (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. 5-HT3 receptor antagonist is added when necessary. 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 from 6 to 8 minutes.
Drug: Dexmedetomidine supplemented morphine analgesia
Patients in this group receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout time from 6 to 8 minutes.
Placebo Comparator: Control group
Morphine analgesia is provided for patients in this group in the form of patient-controlled intravenous analgesia. The formula contains morphine (0.5 mg/ml), diluted with normal saline to a total volume of 160 ml. 5-HT3 receptor antagonist is added when necessary. 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 from 6 to 8 minutes.
Drug: Morphine analgesia
Patients in this group receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout time from 6 to 8 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival after surgery
Time Frame: Up to 7 years after surgery
Overall survival is defined as time interval from index surgery to all-cause death after surgery.
Up to 7 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival after surgery
Time Frame: Up to 7 years after surgery
Recurrence-free survival is defined as time interval from index surgery to cancer recurrence or metastasis or all-cause death, whichever come first.
Up to 7 years after surgery
Cancer-specific survival after surgery
Time Frame: Up to 7 years after surgery
Cancer-specific survival is defined as time interval from index surgery to cancer-specific death; patients who died from other causes will be censored at the time of death.
Up to 7 years after surgery
Event-free survival after surgery
Time Frame: Up to 7 years after surgery
Event-free survival is defined as time interval from index surgery to cancer recurrence or metastasis, new cancer or other major medical events, or all-cause death, whichever come first.
Up to 7 years after surgery
Cognitive function of survival patients at 1 and 2 years after surgery
Time Frame: At the end of 1 and 2 years after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Function-Modified (TICS-M).
At the end of 1 and 2 years after surgery
Quality of life of survival patients at 1 and 2 years after surgery
Time Frame: At the end of 1 and 2 years after surgery
Quality of life is assessed with World Health Organization Quality of Life-Bref (WHOQOL-BREF).
At the end of 1 and 2 years after surgery

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

Collaborators

Peking University International Hospital
Affiliated Hospital of Hebei University
Qingdao Municipal Hospital
The Second Affiliated Hospital of Air Force Medical University
Guizhou Provincial People's Hospital
The Third Xiangya Hospital of Central South University
Shanxi Provincial Cancer Hospital
Tianjin Hospital of ITCWM-Nankai Hospital
Xiyuan Hospital of China Academy of Chinese Medical Sciences
The Third Central Hospital of Tianjin
Chongqing University Fuling Hospital

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)

January 6, 2017

Primary Completion (Actual)

December 11, 2024

Study Completion (Actual)

December 11, 2024

Study Registration Dates

First Submitted

December 31, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimated)

January 6, 2017

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-10-LT

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

product manufactured in and exported from the U.S.

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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