Dexmedetomidine Supplemented Analgesia and Long-term Survival After Cancer Surgery

NCT03012971 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Not applicable

Started

2017-01-06

Last updated

2026-07-28

Condition(s) studied

ElderlySurgeryAnalgesiaDexmedetomidineLong-term Outcome

Investigational drug(s) / intervention(s)

Dexmedetomidine supplemented morphine analgesiaMorphine analgesia

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.

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

65 Years

Max age

90 Years

Healthy volunteers

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.

Primary outcome measure(s)

Overall survival after surgery — Up to 9 years after surgery
Overall survival is defined as time interval from index surgery to all-cause death after surgery.

Trial sites (12)

Facility	City	Region
Peking University First Hospital	Beijing	Beijing Municipality
Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing Municipality
Peking University International Hospital , , China, Contact:	Beijing	Beijing Municipality
Chongqing University Fuling Hospital	Chongqing	Chongqing Municipality
Guizhou Provincial People's Hospital , China, Contact:	Guiyang	Guizhou
Affiliated Hospital of Hebei University	Baoding	Hebei
The Third Xiangya Hospital of Central South University	Changsha	Hunan
The Second Affiliated Hospital of Air Force Medical University	Xi'an	Shaanxi
Qingdao Municipal Hospital , , China, Contact:	Qingdao	Shandong
Shanxi Provincial Cancer Hospital , China, Contact:	Taiyuan	Shanxi
Tianjin Hospital of ITCWM-Nankai Hospital	Tianjin	Tianjin Municipality
The Third Central Hospital of Tianjin	Tianjin	Tianjin Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03012971 on ClinicalTrials.gov ↗ ← All trials in China