Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The incidence of postoperative sleep disturbances by Athens Insomnia Scale
研究概览
简要总结
The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the effects of morning surgery with afternoon surgery on early postoperative sleep function and postoperative recovery under general anesthesia.
详细描述
The circadian rhythm is an intrinsic timing mechanism generated by endogenous systems to adapt to the external environment, which is closely related to the human sleep-wake cycle. Patients after major surgery are prone to changes in sleep structure and sleep quality, called postoperative sleep disturbances (POSD), which are characterized by the total sleep time reduced, rapid eye movement sleep absent, slow wave sleep shortened, and shallow sleep phase increased, times of wakefulness increased, and highly fragmented sleep. Some studies have shown that POSD can aggravate postoperative pain and fatigue, increase postoperative delirium, cardiovascular adverse events, and even cause accidental death of patients. The investigators don't know whether the early postoperative sleep function and postoperative recovery quality of patients undergoing general anesthesia are affected by surgery in the morning or in the afternoon. The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the effects of morning surgery with afternoon surgery on early postoperative sleep function and postoperative recovery under 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
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 18-60 years old.
- •ASA status I or II.
- •BMI 18.5-28 kg/m^
- •performed with laparoscopic myomectomy.
排除标准
- •combining with ovarian disease or ovarian surgery.
- •preoperative Athens Insomnia Scale (AIS) score ≥ 4 points
- •chronic use of sedative, hypnotic, psychotropic drugs.
- •recent night shift, cross-time zone, irregular life routine.
- •suffering from mental illness or hearing, visual impairment, and existing sleep apnea syndrome.
- •patients withdraw, or were unable to complete the trial after surgery.
- •lossed bleeding volume more than 500 ml during surgery.
- •performed procedure time exceeded 2 h.
研究组 & 干预措施
morning group(from 8:00 to 12:00)
干预措施: morning surgery (Other)
afternoon group(from 14:00 to 18:00)
干预措施: afternoon surgery (Other)
结局指标
主要结局
The incidence of postoperative sleep disturbances by Athens Insomnia Scale
时间窗: 1 day after the operation
1. Postoperative sleep disturbances were defined as the total score of Athens Insomnia Scale more than 6. 2. The incidence of postoperative sleep disturbances was defined as the percentage of the population with a score greater than 6
The sleep quality by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
时间窗: 1 day after the operation
The sleep quality: was assessed by the area under curve of BIS (BIS-AUC). The BIS-AUC was calculate using the trapezoidal rule, which used trapezium to approximate the region under a curve and calculate its area (GraphPad Prism Version 5.01; San Diego, California). The smaller BIS-AUC was the better sleep quality.
The sleep efficiency by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
时间窗: 1 day after the operation
The sleep efficiency: was defined as the ratio of a sleeping time over monitoring time.
The sleep time by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
时间窗: 1 day after the operation
The sleep time: was defined as the total time of BIS values less than 80 during monitoring.
次要结局
- The biochemical indicators(6am one day before and one day after the surgery)
- Postoperative recovery Post-operative Quality Recovery Scale(PQRS)(1 day before surgery (T0), 30 minutes after end of anesthesia (T1), and 1 day after surgery (T2))