Impact of Intraoperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Major Non-cardiac Surgery: 3-year Follow-up of a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 619
- 试验地点
- 1
- 主要终点
- Overall survival within 3 years after surgery
研究概览
简要总结
This is a 3-year follow-up of patients enrolled in a previous randomized controlled trial which showed that intraoperative dexmedetomidine reduced delirium in elderly patients after major non-cardiac surgery. The purpose of this study is to clarify the effects of intraoperative dexmedetomidine on long-term outcomes of these patients.
详细描述
Dexmedetomidine is a highly selective α-2-receptor agonist with sedative, analgesic and anxiolytic effects. When used as an supplement during general anaesthesia, it reduces the consumption of the anaesthetics and relieves surgery-related stress response and inflammation. In a recent randomized ontrolled trial of the applicants, 620 elderly patients who underwent major non-cardiac surgery were randomized to receive dexmedetomidine or normal saline during general anesthesia. The results showed that use of dexmedetomidine reduced delirium (5.5% [17/309] with dexmedetomidine vs. 10.2% [32/310] with placebo, P=0.026) and 30-day non-delirium complications (9.4% [60/309] with dexmedetomidine vs. 26.1% [81/310] with placebo, P=0.047) after surgery.
The effects of intraoperative dexmedetomidine on long-term outcomes after surgery remains unclear. In another study of the applicants, use of low-dose dexemeditomidine in ICU patients after surgery increased survival up to 2 years and improve quality of life in 3-year survivors. On the contrary, it was reported in a retrospective study that intraoperative use of dexmedetomidine was associated with shortened overall survival in patients after lung cancer surgery. Therefore, it is urgent to clarify the impact of intraoperative dexemeditomidine on long-term outcomes of patients undergoing major surgery, especially those undergoing cancer surgery.
This study is a 3-year follow-up of patients who were enrolled in a randomzied controlled trial of the applicants in order to clarify the effects of intraoperative dexmedetomidine on long-term outcomes after 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
- •Elderly patients (age ≥60 years);
- •Scheduled to undergo elective major non-cardiac surgery with expected duration ≥2 hours under general anaesthesia.
排除标准
- •Do not provide written informed consent;
- •Previous history of schizophrenia, epilepsy or Parkinson's disease;
- •Visual, hearing, language or other barriers which impede communication and preoperative delirium assessment;
- •History of traumatic brain injury;
- •Severe bradycardia (heart rate <40 beats per minutes), sick sinus syndrome, or atrioventricular block of degree 2 or above without pacemaker;
- •Severe hepatic dysfunction (Child-Pugh grade C);
- •Renal failure (requirement of renal replacement therapy);
- •Neurosurgery.
研究组 & 干预措施
Intervention group
A loading dose of dexmedetomidine (0.6 μg/kg) was administered during a 10-minute period before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery.
干预措施: Dexmedetomidine (Drug)
Control group
Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall survival within 3 years after surgery
时间窗: Up to 3 years after surgery.
Overall survival within 3 years after surgery
次要结局
- Recurrence-free survival within 3 years after surgery.(Up to 3 years after surgery.)
- Cancer-specific survival within 3 years after surgery.(Up to 3 years after surgery.)
- Rate of new-onset disease or hospital readmission within 3 years after surgery.(Up to 3 years after surgery.)
- Quality of life in 3-year survivors.(At 3 years after surgery.)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital