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| Name | Class |
|---|---|
| Affiliated Hospital of Hebei University | OTHER |
| Qingdao Municipal Hospital | OTHER |
| The Second Affiliated Hospital of Air Force Military Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | 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. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival after surgery | Overall survival is defined as time interval from index surgery to all-cause death after surgery. | Up to 7 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 years after surgery |
| Cancer-specific survival after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Xiyuan Hospital of China Academy of Chinese Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7864702 | Background | Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium. A review of 80 primary data-collection studies. Arch Intern Med. 1995 Mar 13;155(5):461-5. doi: 10.1001/archinte.155.5.461. | |
| 22732435 | Background | McDaniel M, Brudney C. Postoperative delirium: etiology and management. Curr Opin Crit Care. 2012 Aug;18(4):372-6. doi: 10.1097/MCC.0b013e3283557211. |
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| Peking University International Hospital |
| OTHER |
| Guizhou Provincial People's Hospital | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Tianjin Hospital of ITCWM-Nankai Hospital | UNKNOWN |
| Chongqing University Fuling Hospital | UNKNOWN |
| The Third Central Hospital of Tianjin | UNKNOWN |
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
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|
| 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. |
|
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 | 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 | 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 | 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 |
| Beijing |
| Beijing Municipality |
| 100091 |
| China |
| Peking University International Hospital , , China, Contact: | Beijing | Beijing Municipality | 102206 | China |
| Chongqing University Fuling Hospital | Chongqing | Chongqing Municipality | 408099 | China |
| Guizhou Provincial People's Hospital , China, Contact: | Guiyang | Guizhou | 550002 | China |
| Affiliated Hospital of Hebei University | Baoding | Hebei | 050031 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| The Second Affiliated Hospital of Air Force Medical University | Xi'an | Shaanxi | 710038 | China |
| Qingdao Municipal Hospital , , China, Contact: | Qingdao | Shandong | 266011 | China |
| Shanxi Provincial Cancer Hospital , China, Contact: | Taiyuan | Shanxi | 030013 | China |
| Tianjin Hospital of ITCWM-Nankai Hospital | Tianjin | Tianjin Municipality | 300100 | China |
| The Third Central Hospital of Tianjin | Tianjin | Tianjin Municipality | 300170 | China |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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