NCT06382961已完成不适用
Postoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Lung Surgery: A Randomized Controlled Trial
Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 287 人开始时间: 2023年11月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :
- Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
- Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.
Participants will undergo routine postoperative care:
- Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
- Postoperative visit twice a day for at least seven days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery for lobectomy or segmentectomy
排除标准
- •local allergy to anesthetics;
- •patients with a clear preoperative history of nervous system and mental system diseases or long-term use of sedatives or antidepressants;
- •history of alcoholism, drug abuse or drug dependence;
- •have a history of brain surgery or injury;
- •epilepsy and associated mental and cognitive dysfunction, long-term stress stimulation, or psychological disorders;
- •sick sinus syndrome, second-degree or greater atrioventricular block or other contraindications for use of α2 adrenergic agonist;
- •liver and kidney insufficiency.
研究组 & 干预措施
Experiment
Experimental
干预措施: Dexmedetomidine injection (Drug)
Control
Active Comparator
干预措施: Sufentanil injection (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Delirium is assessed at 8 am and 8 pm for 3 days after surgery
次要结局
- Incidence of postoperative nausea and vomiting(Assessed twice a day for 7days after surgery)
- incidence of postoperative complications(Assessed daily for 3 days after surgery)
- Pain intensities(Assessed daily at 8 am for 3 days after surgery)
研究者
研究点 (1)
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