Impact of Dexmedetomidine Supplemented Analgesia on Delirium and Long-term Outcomes in Elderly After Hip Fracture Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 1
- 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 hip fracture surgery, and is associated with worse outcomes. The investigators hypothesize that, for elderly patients after hip fracture surgery, dexmedetomidine supplemented analgesia can reduce the incidence of delirium and improve the long-term outcomes.
详细描述
Delirium is a common complication in patients after hip fracture 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.
The etiology of delirium is multifactorial and include severe pain and sleep disturbances after surgery, as well as surgery-related inflammation. Dexmedetomidine is a selective alpha 2 receptor agonist. It exerts sedative effects by activating the endogenous sleep-promoting pathway and leads to a state like non-rapid eye movement sleep. It produces analgesic effects by activating the alpha2a adrenergic receptor subtype in the spinal cord. Perioperative dexmedetomidine also alleviates the degree of surgery-related inflammation.
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 patient-controlled analgesia can also reduce delirium and improve long-term outcomes in elderly patients after hip fracture 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 hip fracture 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
Patients in this group receive dexmedetomidine-supplemented patient-controlled analgesia for up to 3 days after surgery. The formula is a mixture of dexmedetomidine (1 microgram/ml) and sufentanil (1 microgram/ml), diluted with normal saline to 200 ml. The analgesic pump is programmed 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 interval of 8 minutes.
干预措施: Dexmedetomidine (Drug)
Control group
Patients in this group receive routine patient-controlled analgesia for up to 3 days after surgery. The formula is a mixture of placebo and sufentanil (1 microgram/ml), diluted with normal saline to 200 ml. The analgesic pump is programmed 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 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: Up to 5 days after surgery
Delirium is assessed twice daily (8:00-10:00 am, 18:00-20:00 pm) with the 3-minute Diagnostic Confusion Assessment Method (3D CAM, for patients without mechanical ventilation) or the Confusion Assessment Method for the intensive care unit (CAM-ICU, for patients with mechanical ventilation) during postoperative days 1-5.
次要结局
- Incidence of non-delirium complications within 30 days after surgery(Up to 30 days after surgery)
- Cognitive function at 30 days(At the 30th day 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)
- Quality of life at 30 days(At the 30th day 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)
- All-cause 30-day mortality(Up to 30 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)
- Daily prevalence of delirium during the first 5 days after surgery(Up to 5 days after surgery)
- Length of stay in hospital after surgery(Up to 30 days after surgery)
研究者
Dong-Xin Wang
Professor
Peking University First Hospital