Impact of Dexmedetomidine Supplemented Analgesia on Long-term Survival in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 试验地点
- 12
- 主要终点
- Overall survival after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dexmedetomidine group
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.
干预措施: Dexmedetomidine supplemented morphine analgesia (Drug)
Control group
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.
干预措施: Morphine analgesia (Drug)
结局指标
主要结局
Overall survival after surgery
时间窗: Up to 9 years after surgery
Overall survival is defined as time interval from index surgery to all-cause death after surgery.
Overall survival after surgery
时间窗: Up to 7 years after surgery
Overall survival is defined as time interval from index surgery to all-cause death after surgery.
次要结局
- Recurrence-free survival after surgery(Up to 9 years after surgery)
- Cancer-specific survival after surgery(Up to 9 years after surgery)
- Event-free survival after surgery(Up to 9 years after surgery)
- Recurrence-free survival after surgery(Up to 7 years after surgery)
- Cancer-specific survival after surgery(Up to 7 years after surgery)
- Event-free survival after surgery(Up to 7 years after surgery)
- Cognitive function of survival patients at 1 and 2 years after surgery(At the end of 1 and 2 years after surgery)
- Quality of life of survival patients at 1 and 2 years after surgery(At the end of 1 and 2 years after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital