Analgesia, Dexmedetomidine, Elderly, Long-term Outcome, Surgery
Conditions
Keywords
Elderly, Surgery, Analgesia, Dexmedetomidine, Long-term outcome
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.
Interventions
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.
Sponsors
Peking University First Hospital
Affiliated Hospital of Hebei University
Qingdao Municipal Hospital
The Second Affiliated Hospital of Air Force Military Medical University
Peking University International Hospital
Guizhou Provincial People's Hospital
The Third Xiangya Hospital of Central South University
Shanxi Province Cancer Hospital
Tianjin Nankai Hospital
Fuling Central Hospital of Chongqing City
Tianjin Third Central Hospital
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival after surgery | 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. |
| Cancer-specific survival after surgery | 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. |
| Event-free survival after surgery | 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. |
| Cognitive function of survival patients at 1 and 2 years after surgery | At the end of 1 and 2 years after surgery | Cognitive function is assessed with Telephone Interview for Cognitive Function-Modified (TICS-M). |
| Quality of life of survival patients at 1 and 2 years after surgery | 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). |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORDong-Xin Wang, MD, PhD
Peking University First Hospital
Outcome results
None listed