Impact of Perioperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Cardiac Surgery: 6-year Follow-up of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 2
- 主要终点
- Overall survival after surgery
研究概览
简要总结
A retrospective study showed that intraoperative dexmedetomidine administration was associated with decreased risk of 1-year mortality after cardiac surgery. In a previous randomized controlled trial, 285 elderly patients undergoing cardiac surgery were randomized to receive either perioperative dexmedetomidine or placebo (normal saline) administration. The purpose of this 6-year follow-up study is to investigate whether perioperative dexmedetomidine can improve long-term outcomes in those recruited elderly patients after cardiac surgery.
详细描述
Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist that provides anti-anxiety, sedation, and modest analgesic effects. In a retrospective cohort study of patients undergoing cardiac surgery, perioperative dexmedetomidine administration was associated with decreased risk of 1-year mortality. Theoretically, perioperative dexmedetomidine may exert the following favorable for cardiac surgery patients: (1) reduces perioperative opioid consumption and thereby mitigates opioid-induced immunosuppression, (2) dampens hyper-inflammatory response induced by surgery, and (3) improves postoperative sleep quality. However, prospective studies investigating the long-term effects of perioperative dexmedetomidine in cardiac surgery patients are still lacking.
In a previous randomized controlled trial, 285 patients of 60 years or older who were scheduled to undergo coronary artery bypass graft surgery and/or valve replacement surgery were randomized to receive either perioperative dexmedetomidine administration (0.6 microgram/kg in 10 minutes before anesthesia induction, followed by a continuous infusion at a rate of 0.4 microgram/kg/h until the end of surgery, then a continuous infusion at a rate of 0.1 microgram/kg/h until the end of mechanical ventilation) or placebo (normal saline, administered in the same rate or volume for the same duration as in the dexmedetomidine group). The results showed that perioperative dexmedetomidine reduced the incidence of pulmonary complications and shortened the duration of mechanical ventilation after surgery.
The purpose of this 6-year follow-up study is to investigate the effects of perioperative dexmedetomidine on the long-term outcomes in elderly patients after cardiac 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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 60 years or older;
- •Scheduled to undergo cardiac surgery (coronary artery bypass graft and/or valve replacement surgery);
- •Provide written informed consents.
排除标准
- •Patients who meet any of the following criteria will be excluded.
- •Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia;
- •Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier;
- •History of brain injury or neurosurgery;
- •Preoperative sick sinus syndrome, severe bradycardia (HR < 50 bpm), second-degree or above atrioventricular block without pacemaker;
- •Severe hepatic dysfunction (Child-Pugh class C);
- •Severe renal dysfunction (requirement of renal replacement therapy);
- •Other conditions that are considered unsuitable for participation.
研究组 & 干预措施
DEX group
The active drug (dexmedetomidine hydrochloride for injection) will be administered during a period from before anesthesia induction until the end of mechanical ventilation after surgery.
干预措施: dexmedetomidine hydrochloride for injection (Drug)
CTRL group
The placebo drug (normal saline, or 0.9% sodium chloride for injection) will be administered in the same rate and volume for a same duration as that in the DEX group.
干预措施: 0.9% sodium chloride for injection (Drug)
结局指标
主要结局
Overall survival after surgery
时间窗: Up to 6 years after surgery
Overall survival after surgery
次要结局
- Major adverse cardiovascular events-free survival after surgery(Up to 6 years after surgery)
- Hospital-free survival after surgery(Up to 6 years after surgery)
- Cognitive function in 6-year survivors after surgery(At the 6th year after surgery)
- Health related quality of life in 6-year survivors after surgery(At the 6th year after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital