Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery：A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery
研究概览
简要总结
The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are:
- To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep disturbance and sleep quality in patients undergoing spinal surgery.
- To explore the effect of intraoperative infusion of esketamine on postoperative pain, anxiety and depression ; Participants will be patients undergoing spinal surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg/h esketamine or saline will be infused during surgery . The incidence of sleep disturbance , sleep quality, pain scores, hospital anxiety and depression scores and perioperative adverse events after surgery will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old,
- •American Society of Anesthesiologist (ASA) Physical Status classification I to III ;
- •Patients scheduled to undergo elective spinal surgery under general anesthesia;
- •Signed informed consent ;
排除标准
- •BMI > 35kg / m2 ;
- •Severe lesions of important organs and systems ;
- •The estimated duration of surgery is more than 4 hours
- •Patients who were retained tracheal intubation or admitted to intensive care unit (ICU) postoperatively.
- •History of adverse reactions or contraindications to ketamine and esketamine ;
- •Cognitive dysfunction, communication disorders ;
- •Refused to participate in this study.
研究组 & 干预措施
esketamine
Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 .
干预措施: Esketamine (Drug)
saline
Saline will be infused at a speed of 0.3mg / kg / h during surgery .Total intravenous anesthesia with propofol ,remifentanil will be implemented for anesthesia maintenance based on the bispectral index(BIS) and keep BIS between 40-60 .
干预措施: saline (Drug)
结局指标
主要结局
The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery
时间窗: during the first three days after surgery
It will be evaluated by Athens Insomnia Scale (AIS) on the morning(8-10 am) of postoperative days 1-3, a score of 6 or higher will be defined as PSD.
次要结局
- objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment.(on the postoperative day 1 and postoperative day 3 after surgery)
- dosage of analgesics(within 72 hours after surgery)
- Postoperative hospital anxiety and depression scale ( HADS ) score.(on the postoperative day 1 and postoperative day 3 after surgery)
- The pain scores(within 72hours after surgery)
研究者
Ruquan Han
Director
Beijing Tiantan Hospital