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NCT Number: NCT03012971

Dexmedetomidine Supplemented Analgesia and Long-term Survival After Cancer Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine supplemented morphine analgesia

Drug

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.

Morphine analgesia

Drug

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.

Primary outcomes

  1. Overall survival after surgery

    Time frame: Up to 9 years after surgery

    Overall survival is defined as time interval from index surgery to all-cause death after surgery.

Secondary outcomes

  1. Recurrence-free survival after surgery

    Time frame: Up to 9 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.

  2. Cancer-specific survival after surgery

    Time frame: Up to 9 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.

  3. Event-free survival after surgery

    Time frame: Up to 9 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.

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2017
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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