Impact of Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block on Postoperative Delirium and Long-term Oucomes in Elderly Patients After Single Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 主要终点
- Incidence of delirium during the first 3 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. Continuous femoral nerve block is frequently used for postoperative analgesia after total knee arthoplasty. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.
详细描述
A growing number of elderly patients undergo total knee arthroplasty. 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. Dexmedetomidine has been shown to prolong the duration of nerve block without neurotoxicity and improve postoperative sleep quality. The investigators hypothesize that dexmedetomidine, when combined with ropivacaine for continuous femoral nerve block, can reduce the incidence of delirium and improve the long-term outcome in elderly patients after total knee arthroplasty.
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
- •Elderly patients (≥ 65 years but < 90 years);
- •Scheduled to undergo single total knee arthroplasty;
- •Planned to receive continuous femoral nerve block for postoperative analgesia.
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 hemorrhagic disease or coagulopathy (platelet count, prothrombin time and/or activated partial thrombin time below the lower limit of normal);
- •Preoperative obstructive sleep apnea (diagnosed as obstructive sleep apnea, or STOP-Bang score ≥3);
- •Preoperative 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);
- •ASA classification ≥ IV or unlikely to survive for more than 24 hours after surgery.
研究组 & 干预措施
Dexmedetomidine group
For patients in the dexmedetomidine group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours (equivalent to dexmedetomidine infusion at a rate of 0.075 ug/kg/h).
干预措施: Dexmedetomidine (Drug)
Control group
For patients in the control group, postoperative analgesia is provided in the form of continuous femoral nerve block. The formula contains a mixture of 0.2% ropivacaine 250 ml and placebo (normal saline). The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h for 48 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of delirium during the first 3 days after surgery
时间窗: The first 3 days after surgery
Incidence of delirium during the first 3 days after surgery
次要结局
- Length of stay in hospital after surgery(Up to 30 days after surgery)
- Incidence of new-onset diseases within 3 years after surgery(Up to 3 years after surgery)
- Daily prevalence of delirium during postoperative days 1-3(The first 3 days after surgery)
- All-cause 30-day mortality(At 30 days after surgery)
- Quality of life at the end of the 1st, 2nd, and 3rd years after surgery: SF-12(At the end of the 1st, 2nd, and 3rd years after surgery)
- Cognitive function at the end of the 1st, 2nd, and 3rd years after surgery(At the end of the 1st, 2nd, and 3rd years after surgery)
- Incidence of non-delirium complications within 30 days after surgery(Up to 30 days after surgery)
- Quality of life at 30 days after surgery(At 30 days after surgery)
- Cognitive function at 30 days after surgery(At 30 days after surgery)
- Overall survival within 3 years after surgery(Up to 3 years after surgery)
- Survival rates at the end of the 1st，2nd, and 3rd years after surgery(At the end of the 1st, 2nd, and 3rd years after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital