Clinical trial NCT03012971: Dexmedetomidine Supplemented Analgesia and Long-term Survival After Cancer Surgery
Official title: Impact of Dexmedetomidine Supplemented Analgesia on Long-term Survival in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Surgery
Analgesia
Dexmedetomidine
Long-term Outcome
Keywords: Elderly
Surgery
Analgesia
Dexmedetomidine
Long-term outcome
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Hebei University
name: Qingdao Municipal Hospital
name: The Second Affiliated Hospital of Air Force Medical University
name: Beijing Chao Yang Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Beijing Tsinghua Chang Gung Hospital
name: Peking University International Hospital
name: Beijing Ditan Hospital
name: Guizhou Provincial People's Hospital
name: The Third Xiangya Hospital of Central South University
name: Shanxi Provincial Cancer Hospital
name: Tianjin Hospital of ITCWM-Nankai Hospital
name: Zhongda Hospital
First posted: 2017-01-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age \>= 65 years, \< 90 years;
* Scheduled to undergo surgery 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);
* 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 outcomes:
measure: Overall survival after surgery
timeFrame: Up to 7 years after surgery
Secondary outcomes:
measure: Recurrence-free after surgery
timeFrame: Up to 7 years after surgery
measure: Cancer-specific survival after surgery
timeFrame: Up to 7 years after surgery
measure: Event-free survival after surgery
timeFrame: Up to 7 years after surgery
measure: Cognitive function of survival patients at 2 years after surgery
timeFrame: At the end of 2 years after surgery
measure: Quality of life of survival patients at 2 years after surgery
timeFrame: At the end of 2 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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