跳至主要内容
临床试验/NCT04123249
NCT04123249已完成不适用

Effects of Intravenous Anesthetics vs Inhaled Anesthetics on Early Postoperative Sleep Quality and Complications of Patients After Laparoscopic Surgery Under General Anesthesia

Yanchao Yang1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2020年5月20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
74
试验地点
1
主要终点
postoperative sleep quality of one night before surgery

研究概览

简要总结

Adequate sleep is necessary for physical and mental health of human being. Although surgery and anesthesia techniques have improved in resent years, postoperative sleep disturbance remains a challenging problem in surgical procedures1. Postoperative sleep fragmentation and poor sleep quality can not only result in hyperalgesia and a delay in postoperative recovery2, lack of sleep after surgery can also bring many potential adverse effects such as cognitive disorders (such as delusions, delirium), chronic pain, mood disorders, metabolic disorders, and pro-inflammatory changes3-5. Previous studies have reported that age, preoperative comorbidity and severity of surgical trauma were independent factors that associated with postoperative sleep disturbance6,7. Our prior studies have also found that patients are more likely to experience decreased sleep quality after receiving general anesthesia, which was characterized by a decrease in each sleep stage8. Propofol and sevoflurane are commonly used general anesthetics in clinical practice. The choice of anesthetic may also affect the cognitive outcome after surgery, but the results of clinical studies have always been contradictory. Some studies report that the cognitive results after inhalation are worse than those after intravenous anesthesia. And the incidence of dreaming was significantly higher in the sevoflurane anesthesia group compared to the propofol group9-11. Another study conduct among infants proved that compared with propofol-remifentanil, sevoflurane appears to be associated with less sleep disturbances in the first weeks after surgery12. Based on these conflicts, the aim of the current study was to compare the effect of propofol vs sevoflurane on early postoperative sleep quality and complications of patients receiving laparoscopic surgery after general anesthesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA : GradeⅠtoⅡ Laparoscopic surgery

排除标准

  • history of sleep apnea; severe neuropsychiatric disorders; long-term use of sedatives or sleeping pills; can not implement multi-lead sleep monitoring and other sleep disorders

研究组 & 干预措施

Group Propofol

Experimental

In the Group P, propofol 4-6 mg/kg/h and remifentanil 0.2μg/kg/min were infused by intravenous pump separately for assisted sedation and assisted analgesia.

干预措施: Propofol (Drug)

Group Sevoflurane

Experimental

sevoflurane (concentration: 2%-3%, mixed with 50% air and 50% oxygen to keep the minimum alveolar concentration (MAC) at 1.0-1.1) was inhaled to maintain assisted sedation, and remifentanil 0.2 μg/kg/min was infused by intravenous pump for assisted analgesia.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

postoperative sleep quality of one night before surgery

时间窗: one night after the surgery

Use sleep monitor to test the sleep quality one night before surgery

postoperative sleep quality of the first night after surgery

时间窗: the first night after surgery

Use sleep monitor to test the sleep quality the first night after surgery

postoperative sleep quality of the third night after surgery

时间窗: the third night after surgery

Use sleep monitor to test the sleep quality the third night after surgery

次要结局

  • Postoperative pain score(24h after surgery)
  • postoperative adverse effect(24 hours after surgery)

研究者

发起方
Yanchao Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yanchao Yang

Principal investigator

Shengjing Hospital

研究点 (1)

Loading locations...

相似试验