Impact of Dexmedetomidine Supplemented Intravenous Analgesia on Postoperative Delirium and Long-term Outcomes in Elderly After Orthopedic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 2
- 主要终点
- Incidence of delirium within the first 5 days after surgery
研究概览
简要总结
Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. The investigators hypothesize that, for elderly patients after orthopedic surgery, dexmedetomidine supplemented intravenous analgesia can reduce the incidence of delirium and improve the long-term outcomes.
详细描述
A growing number of elderly patients undergo orthopedic surgery each year. Delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. Previous studies showed that, for elderly patients admitted to the intensive care unit after non-cardiac surgery, low-dose dexmedetomidine infusion improved subjective sleep quality and reduced delirium early after surgery; it also increased survival up to 2 years and improved life quality in 3-year survivors. The investigators hypothesize that dexmedetomidine supplemented intravenous analgesia (in the form of patient-controlled analgesia) can also reduce delirium and improve long-term outcomes in elderly patients after orthopedic surgery.
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 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years but < 90 years;
- •Scheduled to undergo total knee/hip replacement surgery, or spinal surgery;
- •Planned to use patient-controlled intravenous analgesia (PCIA) after surgery.
排除标准
- •Refuse to participate in this study;
- •Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
- •Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
- •Preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
- •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);
- •Severe renal dysfunction (requirement of renal replacement therapy before surgery);
- •American Society of Anesthesiologists physical status >IV, or estimated survival ≤24 h.
研究组 & 干预措施
Dexmedetomidine group
For patients in the dexmedetomidine group, postoperative analgesia is provided in the form of patient-controlled intravenous analgesia. The formula contains a mixture of sufentanil (1.25 ug/ml) and dexmedetomidine (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a patient-controlled bolus of 2 ml each time and a lockout interval of 8 minutes.
干预措施: Dexmedetomidine (Drug)
Control group
For patients in the control group, postoperative analgesia is provided in the form of patient-controlled intravenous analgesia. The formula contains a mixture of placebo and sufentanil (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a patient-controlled bolus of 2 ml each time and a lockout interval of 8 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of delirium within the first 5 days after surgery
时间窗: The first 5 days after surgery
Incidence of delirium within the first 5 days after surgery
次要结局
- Daily prevalence of delirium during the first 5 days after surgery(The first 5 days after surgery)
- Overall survival for up to 3 years after surgery(Up to 3 years after surgery)
- Event-free survival for up to 3 years after surgery(Up to 3 years after surgery)
- Incidence of non-delirium complications with 30 days after surgery(Up to 30 days after surgery)
- Agitation or sedation level during postoperative days 1-5(The first 1-5 days after surgery)
- Cumulative sufentanil consumption within 5 postoperative days(Up to 5 days after surgery)
- Quality of life in 1-，2- and 3-year survivors after surgery(At the end of the 1st, 2nd, and 3rd year after surgery)
- Length of stay in hospital after surgery(Up to 30 days after surgery)
- All-cause 30-day mortality(Up to 30 days after surgery)
- Quality of life of 30-day survivors(At 30 days after surgery)
- Cognitive function of 30-day survivors(At 30 days after surgery)
- Subjective sleep quality during postoperative days 1-5(The first 1-5 days after surgery)
- Pain severity during postoperative days 1-5(The first 1-5 days after surgery)
- Cognitive function in 1-，2- and 3-year survivors after surgery(At the end of the 1st, 2nd, and 3rd year after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital