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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,500
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.
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.
Peking University First Hospital
Beijing, Beijing Municipality, China
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Peking University International Hospital , , China, Contact:
Beijing, Beijing Municipality, China
Chongqing University Fuling Hospital
Chongqing, Chongqing Municipality, China
Guizhou Provincial People's Hospital , China, Contact:
Guiyang, Guizhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
Qingdao Municipal Hospital , , China, Contact:
Qingdao, Shandong, China
Shanxi Provincial Cancer Hospital , China, Contact:
Taiyuan, Shanxi, China
...and 2 more locations
Overall survival after surgery
Overall survival is defined as time interval from index surgery to all-cause death after surgery.
Time frame: Up to 7 years after surgery
Recurrence-free survival 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.
Time frame: Up to 7 years after surgery
Cancer-specific survival 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.
Time frame: Up to 7 years after surgery
Event-free survival 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.
Time frame: Up to 7 years after surgery
Cognitive function of survival patients at 1 and 2 years after surgery
Cognitive function is assessed with Telephone Interview for Cognitive Function-Modified (TICS-M).
Time frame: At the end of 1 and 2 years after surgery
Quality of life of survival patients at 1 and 2 years after surgery
Quality of life is assessed with World Health Organization Quality of Life-Bref (WHOQOL-BREF).
Time frame: At the end of 1 and 2 years after surgery
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