Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Sleep Quality
研究概览
简要总结
The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are:
Does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better? The researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances.
Participants will:
- Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery
- Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class II-III, NYHA class I-III, EF ≥ 50%
- •Intended to perform cardiac surgery under extracorporeal circulation
排除标准
- •Patients undergoing second heart surgery
- •Patients with mental retardation, deafness, or other conditions that interfere with normal communication
- •Previous neurological or psychiatric disorders
- •Patients with a history of sleep disorders
- •Alcoholics, drug addicts, or psychotropic substance abusers
- •Significant hepatic or renal dysfunction affecting drug metabolism
- •Contraindication to the use of dexmedetomidine or esketamine.
研究组 & 干预措施
dexmedetomidine group
Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
干预措施: Intraoperative infusion of dexmedetomidine (Drug)
esketamine group
Intraoperative infusion of 0.3mg/kg/h esketamine
干预措施: Intraoperative infusion of esketamine (Drug)
control group
Intraoperative infusion of equal volumes of saline
干预措施: Saline control (Drug)
结局指标
主要结局
Sleep Quality
时间窗: 1, 3, 7days after surgery
Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device
次要结局
- anxiety and depression assessment(1,3 days after surgery)
- Postoperative complications(48 hours after surgery)
- postoperative pain(24 hours and 48 hours after surgery)
- Record postoperative analgesic medications used and the amount used for postoperative pain(24 hours and 48 hours after surgery)
- Postoperative delirium(from 1 day to 7 days after surgery)